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a b/clusters/3009knumclusters/clust_11.txt
1
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
2
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:\r\n* Active cardiac disease\r\n** Angina pectoris that requires the current use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; or\r\n** Symptomatic pericarditis\r\n* History of cardiac disease\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function;\r\n** History of documented congestive heart failure (CHF); or\r\n** Documented cardiomyopathy
3
Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)\r\n* Note: Patients with history of CHF or patients who are deemed at risk because of underlying cardiovascular disease or exposure to cardiotoxic drugs should have an electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at baseline and at the start of each cycle; patients who have evidence at baseline (or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist, including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram, as clinically indicated
4
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
5
Patients must not have any grade II/III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia; abnormal cardiac valve morphology (>= grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis]) can be entered on study; patients with a history of atrial fibrillation must have atrial fibrillation controlled for at least 30 days prior to registration
6
No cardiac arrhythmias within 182 days of registration
7
There are no minimal organ function requirements for enrollment on this study\r\n* Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria
8
Unstable angina pectoris or cardiac arrhythmia (except atrial fibrillation);
9
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
10
Patients with a history of coronary artery disease may be included if they have had a normal cardiac stress test within 30 days of enrollment
11
Impaired cardiac function or clinically significant cardiac disease.
12
History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:
13
Impaired cardiac function or clinically significant cardiac disease
14
Impaired cardiac function or clinically significant cardiac disease, including any of the following (Criteria a through g):
15
Uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
16
Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
17
Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
18
Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
19
Shortening fraction of >= 27% by echocardiogram (while not receiving medications for cardiac function), or
20
Impaired cardiac function
21
Any of the following cardiac conditions:
22
Impaired cardiac function or clinically significant cardiac disease.
23
Impaired cardiac function or clinically significant cardiac disease
24
Current evidence of cardiac ischemia
25
Uncontrolled cardiac disease
26
- Patient presenting with cardiac disorders defined by at least one of the following conditions:
27
Patient with recent cardiac history (within 6 months) of:
28
Symptomatic cardiac disease
29
Cardiac ejection fraction < 30% (or, if unable to obtain ejection fraction, shortening fraction < 26%) on multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (echo), symptomatic coronary artery disease, or other cardiac failure requiring therapy; patients with a history of, or current cardiac disease should be evaluated with appropriate cardiac studies and/or cardiology consult; patients with a shortening fraction of < 26% must be seen by cardiology for approval
30
Uncontrolled cardiac arrhythmia (subjects with rate-controlled atrial fibrillation are not excluded).
31
Have a serious cardiac condition.
32
Subject has any neuropathy > Grade 1. 5. Subject has impaired cardiac function or clinically significant cardiac diseases, including any of the following:
33
Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; or symptomatic pericarditis.
34
History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function within 6 months prior to randomization; history of documented CHF; or documented cardiomyopathy.
35
Participant has active cardiac disease or a history of cardiac dysfunction including any of the following:
36
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement
37
Any subject with a history of significant renal, hepatic, pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac dysfunction
38
history of or current cardiac issues
39
Have experienced any of the following within the 6-month period prior to Screening: unstable angina pectoris, clinically significant coronary artery disease, cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia
40
EXCLUSION - PROCUREMENT: Cardiac criteria: prolonged QT syndrome; atrial fibrillation/flutter; myocardial infarction within the last 12 months; cardiac echocardiography with left ventricular systolic function (LVSF) ? 30% or left ventricular ejection fraction (LVEF) ? 50%; cardiac dysfunction New York Heart Association (NYHA) III or IV; cardiac echocardiography with clinically significant pericardial effusion
41
EXCLUSION - TREATMENT: Cardiac criteria: prolonged QT syndrome; atrial fibrillation/flutter; myocardial infarction within the last 12 months; cardiac echocardiography with LVSF ? 30% or LVEF ? 50%; cardiac dysfunction NYHA III or IV; cardiac echocardiography with clinically significant pericardial effusion
42
Adequate Cardiac Function defined as shortening fraction of >=27% by echocardiogram (while not receiving medications for cardiac function), or ejection fraction of >= 50% by gated radionuclide study (while not receiving medications for cardiac function), the corrected QTc interval by Bazett's formula (QTcB) <450 milliseconds (msec), and must not have a history of myocardial infarction, severe or unstable angina, peripheral vascular disease or familial QTc prolongation.
43
History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias
44
EXCLUSION CRITERIA FOR REGISTRATION: History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias
45
Any history of CTCAE grade ?2 non-dysrhythmia cardiac conditions within the last 6 months. Patients with asymptomatic grade 2 non-dysrhythmia cardiac conditions may be considered for inclusion, with the approval of the medical monitor, if stable and unlikely to affect patient safety.
46
Clinically significant cardiac disease or impaired cardiac function
47
History of arrhythmia requiring an implantable cardiac defibrillator
48
Any of the following cardiac criteria:
49
Adequate cardiac left ventricular function
50
Having clinically significant cardiac disease such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic CHF
51
Have a history of cardiac dysfunction including:
52
Impaired cardiac function or clinically significant cardiac disease.
53
Any of the following cardiac criteria:
54
Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity
55
Impaired cardiac function or clinically significant cardiac disease.
56
Subject is undergoing one of the following open elective cardiac, general, or urological surgical procedures: Cardiac procedure (Epicardium); Cardiac procedure (aortic anastomosis or aortotomy suture line); Liver resection; Total splenectomy; On-clamp partial nephrectomy; or Radical nephrectomy.
57
Subject is undergoing one of the following elective procedures: Cardiac procedure (Epicardium); Cardiac procedure (Aortic Anastomosis or Aortotomy suture line); Liver resection; Total splenectomy; On-clamp partial nephrectomy; or Radical nephrectomy.
58
History of cardiac or aortic surgery,
59
Medical suitability for resection, including documented medical and cardiac clearance
60
Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
61
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
62
Any cardiac finding that is deemed ineligible at the discretion of the investigator
63
Cardiac: Shortening fraction >= 28%
64
Known cardiac arrhythmias requiring medication.
65
No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than one year prior to entry, serious cardiac arrhythmias, or unstable angina; patients who are over 40 or have had previous cardiac disease will be required to have a negative or low probability cardiac stress test for cardiac ischemia
66
No presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
67
Cardiac failure, class I-IV
68
Any of the following cardiac criteria:
69
Significant cardiac abnormalities
70
Current cardiac arrhythmic condition requiring concurrent use of anti-arrhythmic drug; rate controlled atrial fibrillation is allows
71
Cardiac arrhythmia not controlled with medical management, evidence of pericardial effusion on imaging that is compromising function
72
Have a significant cardiac condition.
73
Current significant cardiac conduction abnormalities and hypokalemia as specified in the protocol.
74
Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease
75
Clinically significant cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded.
76
Have a serious cardiac condition.
77
Resting QTcF ?470 msec at pretreatment (baseline) or other cardiac or cardiac repolarization abnormality
78
Impaired cardiac function.
79
Has cardiac pathology, defined as:
80
Unstable angina pectoris or cardiac ventricular arrhythmia.
81
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement
82
Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: \r\n*Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device.
83
Cardiac stress test within past 6 months without evidence of reversible ischemia
84
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Patients with electrocardiogram (EKG) within 14 days of initiation of chemotherapy demonstrating no new significant rhythm, axis or ST segment changes will be included; if clinically significant, new EKG changes are present, patients may be included if cardiac stress test indicates no reversible cardiac ischemia
85
Patients with known cardiac shunts
86
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
87
Any history of clinically significant cardiac arrhythmia, coronary revascularization, ischemic symptoms, or previously documented left ventricular ejection fraction (LVEF) of less than or equal to 45%; a cardiac stress test is required for all patients greater than 50 years old; a cardiac stress test may also be performed for any clinical concern; patients with cardiac ischemia are not eligible
88
History of the following cardiac conditions:
89
Congestive cardiac failure of >Grade II severity according to the NYHA;
90
Impaired cardiac function
91
Absence of uncontrolled cardiac arrhythmia
92
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
93
Free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia; the ejection fraction by gated cardiac blood flow scan (MUGA) or echocardiogram must be > 40%
94
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
95
Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen; this includes but is not confined to: \r\n* Active cardiac diseases including: \r\n** Symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention\r\n** Ventricular arrhythmias except for benign premature ventricular contractions\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n** Conduction abnormality requiring a pacemaker\r\n** Valvular disease with documented compromise in cardiac function\r\n** Symptomatic pericarditis \r\n* History of cardiac disease:\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function\r\n** History of documented congestive heart failure (CHF) \r\n** Documented cardiomyopathy
96
Clinically significant cardiovascular abnormalities (e.g., congestive heart failure or symptoms of coronary artery disease), as determined by medical history and physical examination; patients with a history of cardiac disease must have a normal cardiac stress test (treadmill, echocardiogram, or myocardial perfusion scan) within the past 6 months of study entry
97
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
98
History/presence of arrhythmia (even controlled) on chemical anti-arrhythmic(s) must have cardiac consult to ensure the subject could safely proceed with protocol requirements
99
History of arrhythmia requiring an implantable cardiac defibrillator.
100
Current cardiac arrhythmia requiring concurrent use of anti-arrhythmic drugs
101
Evidence or history of significant cardiac disease (including evidence or history of significant cardiac disease (including myocardial infarction [MI] in the past 6 months, significant cardiac arrhythmia, stage III or IV congestive heart failure [CHF]); cardiac stress test will be done as clinically indicated; (the specific test to be chosen at the discretion of the principal investigator [PI])
102
Electrocardiogram without evidence of acute cardiac ischemia
103
Symptomatic atrial fibrillation or other cardiac arrhythmia for which the therapy is not stable or requiring changes in therapy within 1 month of treatment initiation; atrial fibrillation or other cardiac arrhythmia which is clinically stable on stable therapy is allowed
104
Cardiac disease that would preclude administration of the drugs included in the study treatment regimen including, but not limited to:\r\n* Angina pectoris that requires the current use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with documented compromise in cardiac function; and symptomatic pericarditis
105
Any of the following cardiac criteria:
106
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
107
Certain cardiac abnormalities or history
108
Left ventricular ejection fraction >= 45%, assessed within 3 months prior to registration, e.g. by multigated acquisition scan (MUGA) scan or echocardiography, or other appropriate diagnostic modality and no clinical evidence of congestive heart failure; if the patient had anthracycline-based therapy since the most recent cardiac assessment, cardiac evaluation should be repeated if there is clinical or radiographic suspicion of cardiac dysfunction, or if the previous cardiac assessment was abnormal
109
Light chain (AL) amyloidosis patients with Mayo cardiac stage III (defined as N-terminal proB-type natriuretic peptide measurement [proBNP] > 332 ng/L and cardiac troponin [cTnT] > 0.035 ug/L)
110
Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death
111
The patient has cardiac conditions defined per protocol
112
Patients with cardiac ventricular arrhythmias requiring anti-arrhythmic therapy are not eligible
113
Patients who have a history of significant cardiac disease, cardiac disease risk factors or uncontrolled arrhythmias are NOT eligible for either Stratum
114
Cardiac ejection fraction < 40% or symptomatic coronary artery disease or uncontrolled arrhythmia
115
Heart conditions - any of the following:\r\n* Any atrial fibrillation =< 3 months prior to registration\r\n* Unstable angina =< 12 months prior to registration\r\n* Prior symptomatic congestive heart failure\r\n* Documented myocardial infarction =< 6 months prior to registration (pretreatment electrocardiogram [ECG] evidence of infarct only will not exclude patients)\r\n* Prior significant ventricular arrhythmia requiring medication\r\n* Prior 2nd or 3rd degree heart block or other types of clinically significant conduction delay =< 6 months prior to registration\r\n* Clinically significant pericardial disease (including pericardial effusion, pericarditis) or cardiac valvular disease =< 12 months prior to registration\r\n* NOTE: As part of history and physical, all patients must be assessed for signs or symptoms of cardiac disease, or for prior history of cardiac disease; these conditions include but are not limited to diseases related to cardiac valves, pericardium, myocardium, atrioventricular delays or arrhythmias; it is strongly recommended that signs or symptoms of potentially clinically significant disease be evaluated with comprehensive cardiac echo
116
The subject has a history of advanced cardiac, hepatic or renal disease or other chronic illness
117
History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease
118
cardiac conditions, including
119
Patients who are greater than age 50, or who have a history of coronary artery disease, will be required to undergo cardiac stress testing within 6 months of screening and will be excluded if there is evidence of reversible ischemia
120
Impaired cardiac function or clinically significant cardiac diseases
121
No uncontrolled arrhythmias or symptomatic cardiac disease
122
For patients designated to be treated on Group 2: cardiac ejection fraction >= 35%; for patients with significant risk factors for coronary artery disease (Framingham risk score > 15%), a cardiac stress test is recommended
123
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
124
Participants with impaired cardiac function or clinically significant cardiac disease.
125
Impaired cardiac function or history of cardiac problems
126
Unstable/inadequate cardiac function:
127
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
128
Any of the following cardiac criteria:
129
Active or unstable cardiac disease or heart attack within 3 months of starting study treatment
130
Have experienced symptomatic cardiac disease that is unresponsive to surgical or medical management
131
Cardiac function suitable for protocol-required hydration as determined by the investigator and/or cardiologist
132
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
133
Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram
134
History of heart failure or cardiac arrhythmia
135
No uncontrolled arrhythmias or symptomatic cardiac disease
136
A stress cardiac test (stress thallium, stress multi-gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 1 month of lymphodepletion
137
History of cardiac ventricular arrhythmias requiring anti-arrhythmic therapy within past 3 months
138
Serious cardiac condition within the last 6 months
139
Donor must not have any medical condition which would make apheresis more than a minimal risk, and should have the following: \r\n* Family members will be considered for donation if they do not have a history of known cardiac problem and do not have abnormal cardiac findings by physical examination; those with a history of cardiac problems or abnormal cardiac findings by physical examination should undergo a stress evaluation or be evaluated by a cardiologist and deemed eligible to donate
140
If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines\r\n* Patients with the following risk factors should have a baseline cardiac function assessment:\r\n** Prior treatment with anthracyclines\r\n** Prior treatment with trastuzumab\r\n** Prior central thoracic radiation therapy (RT), including RT to the heart\r\n** History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)\r\n** Prior history of impaired cardiac function
141
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
142
Have cardiac pacemakers
143
Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, must have a LVEF > 50% within 12 weeks prior to randomization.
144
Active cardiac disease: symptomatic angina pectoris within the past 90 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis
145
History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; history of documented congestive heart failure (CHF); and documented cardiomyopathy
146
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators
147
Adequate cardiac function defined as no history of clinically significant arrhythmia, or history of myocardial infarction (MI) within 3 months prior to study enrollment; cardiac function will be assessed by history and physical examination
148
Patient must have normal cardiac function documented by ejection fraction (> 55%) documented by echocardiogram or radionuclide MUGA evaluation or fractional shortening ( > 27%) documented by echocardiogram and EKG must demonstrate no abnormality severe enough to justify cardiac medications and baseline QTc interval less than or equal to 450 msecs
149
Patients requiring anti-arrhythmia cardiac medications are NOT eligible
150
History of any cardiac events including coronary revascularization or ischemic symptoms
151
Not requiring pressor support, not having symptomatic cardiac arrhythmias
152
Not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension
153
Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension
154
Cardiovascular criteria: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension
155
No symptoms of uncontrolled cardiac disease
156
Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography.
157
History of any cardiac events including coronary revascularization or ischemic symptoms
158
A stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II)
159
History of cardiac disease, in particular, supraventricular tachycardia
160
A stress cardiac test (stress thallium, stress multigated acquisition [MUGA] scan, dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II)
161
Active heart (cardiac) disease as defined in the protocol
162
Evidence of clinically significant cardiac disease at diagnosis, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac impairment due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
163
Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia
164
Cardiac pacemaker.
165
No active co-morbid cardiac condition such as active CHF or CAD
166
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
167
Symptomatic atrial fibrillation, or other symptomatic cardiac arrhythmia
168
Clinically significant cardiac disease or impaired cardiac function, including any of the following:
169
Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 20%)
170
Patient with history of cardiac arrest within the past 6 months
171
Adequate cardiac reserve with a cardiac ejection fraction within the lower limit of facility normal by MUGA, or 50% by echocardiogram
172
Patients with symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
173
A stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria)
174
Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to first dose of study drugs are eligible)
175
Significant cardiac abnormalities;
176
Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.
177
Any of the following cardiac conditions:
178
Any of the following cardiac criteria:
179
> Class II Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
180
Cardiac or cardiac repolarization abnormality
181
Patients who have impaired cardiac function or clinically significant cardiac diseases,
182
Myocardial infarction, cardiac arrest or cardiac failure within 1 year before screening/baseline visit;
183
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
184
Patients with unstable cardiac status including:
185
Patient presenting with at least one of the following feature: ischemic heart disease, cardiac failure, conduction disorders or arrythmia
186
Impaired cardiac function or history of cardiac problems
187
Electrocardiogram without evidence of acute cardiac ischemia <= 21 days prior to randomization.
188
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:\r\n* Active cardiac disease\r\n** Angina pectoris that requires the current use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; or\r\n** Symptomatic pericarditis\r\n* History of cardiac disease\r\n** Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;\r\n** History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%; or\r\n** Documented cardiomyopathy
189
Cardiac conditions per protocol
190
Normal/negative cardiac stress testing with myocardial perfusion imaging OR cardiac catheterization with non-significant angiogram findings reviewed by a cardiology consultant (dose level 3 and >= 40 years old)
191
Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
192
Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
193
ENROLLMENT: Uncontrolled arrhythmias or uncontrolled symptoms of cardiac disease noted by screening history and physical. Patients with known cardiac dysfunction should have an ejection fraction (EF) > 40% documented by echocardiogram (ECHO).
194
Significant cardiovascular abnormalities including any one of the following: Congestive heart failure, Clinically significant hypotension, symptoms of coronary artery disease, presence of cardiac arrhythmias on electrocardiography (EKG) requiring drug therapy; or patients with a history of cardiovascular disease. (Patients with the above will undergo a cardiac evaluation which can include a stress test and/or echocardiography. Results of this evaluation will be considered before excluding patients on the basis of cardiovascular abnormalities). Subjects with evidence of stress-induced cardiac ischemia or ejection fraction less than 55% will be excluded.
195
Patients with intra-cardiac defibrillators
196
Cardiac arrhythmias
197
Have any condition that increases the risk of abnormal ECG or cardiac arrhythmia
198
Participant has active cardiac disease including any of the following:\r\n* Angina pectoris that requires the use of anti-anginal medications\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with document compromise in cardiac function\r\n* Symptomatic pericarditis
199
Impaired cardiac function or clinically significant cardiac disease
200
Uncontrolled cardiac arrhythmia
201
Active or clinically significant cardiac disease including any of the following:\r\n* Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment\r\n* Myocardial infarction within 6 months prior to initiating study treatment\r\n* Cardiac arrhythmias currently requiring anti-arrhythmic therapy other than beta blockers
202
If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines\r\n* Patients with the following risk factors should have a baseline cardiac function assessment:\r\n** Prior treatment with anthracyclines\r\n** Prior treatment with trastuzumab\r\n** Prior central thoracic radiation therapy (RT), including RT to the heart\r\n** History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)\r\n** Prior history of impaired cardiac function
203
Normal cardiac function; patients who have a history of heart disease, or who are over the age of 50 years must have a normal cardiac stress test within the prior 90 days
204
Subjects with significant cardiac issues
205
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
206
Any of the following cardiac abnormalities or history
207
Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 27%)
208
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\r\n* Acute myocardial infarction or angina pectoris =< 6 months prior to starting study drug
209
Uncontrolled cardiac arrhythmia - patients with rate-controlled atrial fibrillation are not excluded
210
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
211
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
212
History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
213
Clinically significant cardiovascular abnormalities (e.g., congestive heart failure or symptoms of coronary artery disease), as determined by medical history and physical examination; patients with a history of cardiac disease must have a normal cardiac stress test (treadmill, echocardiogram, or myocardial perfusion scan) within the past 6 months of study entry
214
History of arrhythmia requiring an implantable cardiac defibrillator
215
History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
216
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:\r\n* Active cardiac disease:\r\n** Angina pectoris that requires the use of anti-anginal medication;\r\n** Ventricular arrhythmias except for benign premature ventricular contractions;\r\n** Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;\r\n** Conduction abnormality requiring a pacemaker;\r\n** Valvular disease with documented compromise in cardiac function; and\r\n** Symptomatic pericarditis\r\n*History of cardiac disease:\r\n** Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;\r\n** History of documented congestive heart failure (CHF); and\r\n** Documented cardiomyopathy
217
Patient with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction < 28%) NOT due to mediastinal mass
218
Patients with electrocardiogram (EKG) within 14 days of initiation of chemotherapy demonstrating no new rhythm, axis or ST segment changes will be included; if clinically significant, new EKG changes are present, patients may be included if cardiac stress test indicates no cardiac ischemia
219
A stress cardiac test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within 6 months of lymphodepletion in those over 50 years of age or with a known history coronary artery disease
220
Patients with recent (? 6 months) cardiac angina, difficult to control congestive\n             heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias\n             will be excluded
221
Cardiac arrhythmia requiring maintenance medication
222
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
223
Patients must not have serious and inadequately controlled cardiac arrhythmia
224
Serious cardiac arrhythmia requiring medication
225
Cardiac ejection fraction < 30% or, if unable to obtain ejection fraction, shortening fraction of < 26%) on multi-gated acquisition (MUGA) scan or cardiac echo, symptomatic coronary artery disease, other cardiac failure requiring therapy; patients with a history of, or current cardiac disease should be evaluated with appropriate cardiac studies and/or cardiology consult; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist
226
Decreased cardiac function with NYHA > Class 2
227
Impaired cardiac function or clinically significant cardiac disease
228
Significant history or risk of cardiac disease
229
Cardiac arrhythmia not controlled with medical management
230
History of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
231
Unstable cardiac disease including angina or hypertension as defined by the need for overnight hospital admission within the last 3 months (90 days).
232
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
233
Cardiac involvement is defined as the presence of a mean left ventricular wall thickness on echocardiogram greater than 12 mm in the absence of other potential causes of left ventricular hypertrophy (controlled hypertension is allowed) with a noncardiac biopsy showing amyloid, or a positive cardiac biopsy in the presence of clinical or laboratory evidence of involvement. If there is isolated cardiac involvement, then typing of amyloid deposits is recommended.
234
Unstable/inadequate cardiac function:
235
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
236
Serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA
237
Significant active cardiac disease within the previous 6 months
238
Cardiac angioplasty or stenting
239
Significant active cardiac disease within the previous 6 months prior to signing the ICF, including:
240
Significant cardiac arrhythmia
241
History or current evidence of cardiac arrhythmia and/or conduction abnormality
242
Patients must not have symptomatic congestive heart failure, coronary artery disease, cardiomyopathy, or uncontrolled arrhythmias; either an echocardiogram or multi-gated acquisition (MUGA) scan with an ejection fraction >= 45% must be obtained within 28 days prior to registration, or within 14 days prior to registration if the patient has received anthracycline in the 28 day window; (either method for measuring cardiac function is acceptable; however, the same scan must be used throughout treatment and follow-up to monitor the patient for cardiac toxicity); if the patient has symptoms suggestive of ischemia or congestive heart failure after that cardiac evaluation was done, a repeat study must be obtained prior to registration
243
Any of the following cardiac conditions:
244
No history of ventricular arrhythmias or severe cardiac dysfunction
245
Significant active cardiac disease within the previous 6 months from the signing of the ICD, including:
246
Significant active cardiac disease within the previous 6 months, including:
247
Significant cardiac arrhythmia or unstable angina or angina requiring surgical or medical intervention; and/or
248
Cardiac:
249
Cardiac Troponin I within normal limit.
250
History of ischemic cardiac disease that has occurred within 6 months prior to study entry.
251
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
252
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
253
Impaired cardiac function
254
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
255
Significant cardiac event within 12 months before Cycle 1 Day 1.
256
History of arrhythmia requiring an implantable cardiac defibrillator;
257
Clinically significant active cardiac disease, uncontrolled heart disease and/or history of cardiac dysfunction including any of the following
258
No Severe or Chronic medical conditions including gastrointestinal abnormalities or significant cardiac history
259
Clinically significant (i.e. active) cardiac disease (e.g. symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, or myocardial infarction within the last 6 months); any history of clinically significant cardiac failure
260
Abnormal cardiac status
261
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
262
History or evidence of cardiac disease as indicated by any of the following:
263
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
264
Serious and inadequately controlled cardiac arrhythmia
265
Patient has active cardiac disease or a history of cardiac dysfunction
266
Uncontrolled or significant cardiac disease
267
Patients with a known history of cardiac disease. This includes:
268
Cardiac abnormalities
269
Known cardiac metastases
270
Uncontrolled cardiac or coronary artery disease
271
Left ventricular ejection fraction >= 45%, assessed within 3 months prior to study day 0, e.g. by multi gated acquisition scan (MUGA) scan or echocardiography, or other appropriate diagnostic modality and no clinical evidence of congestive heart failure; if the patient had anthracycline-based therapy since the most recent cardiac assessment, cardiac evaluation should be repeated if there is clinical or radiographic suspicion of cardiac dysfunction, or if the previous cardiac assessment was abnormal
272
A functional cardiac test (e.g., stress treadmill, stress thallium, multigated acquisition scan (MUGA), dobutamine echocardiogram) to rule out cardiac ischemia within 4 months prior to lymphodepletion is required for all patients
273
Pre-existing known cardiovascular abnormalities as defined by any one of the following: \t\r\n* Congestive heart failure \r\n* Clinically significant hypotension \r\n* Cardiac ischemia, or symptoms of coronary artery disease\r\n* Presence of cardiac arrhythmias on electrocardiogram (EKG) requiring drug therapy\r\n* Ejection fraction < 45% (echocardiogram or MUGA), although any patient with an ejection fraction between 45-49% must receive clearance by a cardiologist to be eligible for Step II of the trial
274
Pre-existing known cardiovascular abnormalities as defined by any one of the following: \t\r\n* Congestive heart failure \r\n* Clinically significant hypotension \r\n* Cardiac ischemia, or symptoms of coronary artery disease\r\n* Presence of cardiac arrhythmias on EKG requiring drug therapy\r\n* Ejection fraction < 45%, although any patient with an ejection fraction between 45-49% must receive clearance by a cardiologist to be eligible for Step II of this trial
275
Cardiac disease or dysfunction.
276
Cardiac abnormalities
277
Impaired cardiac function or clinically significant cardiac disease
278
Patients with impaired cardiac function or clinically significant cardiac disease.
279
Impaired cardiac function or clinically significant cardiac diseases.
280
Clinically significant cardiac disease or impaired cardiac function, including any of the following:
281
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity (e.g. congestive heart failure, symptomatic coronary artery disease and/or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, or ongoing infection as manifested by fever
282
Any of the following cardiac conditions:
283
Known cardiac metastases
284
Have abnormal cardiac findings.
285
Patients with third degree or complete heart block are not eligible unless a pacemaker is in place; patients on medications, which alter cardiac conduction, such as digitalis, beta-blockers, or calcium channel blockers, or who have other conduction abnormalities or cardiac dysfunction could be entered at the discretion of the investigators
286
Cardiac arrhythmia
287
Pre-existing cardiac conditions
288
No evidence of significant cardiac or pulmonary dysfunction
289
Anyone with cardiac abnormalities or history
290
Cardiac disease
291
Have a serious concomitant systemic disorder or significant cardiac disease.
292
Cardiac arrhythmia requiring medical management and/or pacemaker
293
Cardiac arrhythmias requiring anti-arrhythmic therapy; Note: pace makers, beta blockers, or digoxin are permitted
294
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
295
Any of the following cardiac criteria:
296
Active cardiac disease
297
Significant active cardiovascular or pulmonary disease at study entry ? History of arrhythmia requiring an implantable cardiac defibrillator
298
Presence of a cardiac pacemaker
299
Clinically significant cardiac arrhythmias and/or patients who require anti-arrhythmic therapy (excluding beta blockers or digoxin); patients with controlled atrial fibrillation are not excluded
300
Any of the following cardiac diseases currently or within the last 6 months:
301
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
302
A requirement for positive inotropic support (excluding digoxin) or serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation) within 1 year prior to screening
303
Not requiring pressor support, not having symptomatic cardiac arrhythmias
304
Cardiac angioplasty or stenting
305
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
306
Cardiac troponin I or cardiac troponin T levels above the limit of normal as specified by the manufacturer.
307
Significant cardiac impairment
308
History of myocardial infarctions or cardiac stent placement less than 1 year before recruitment into the study
309
Unable to receive background chemotherapy based on prior treatment history and cardiac function
310
Any of the following cardiac criteria:
311
Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy
312
Presence of cardiac metastases
313
Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
314
Atrial fibrillation or other cardiac arrhythmia requiring therapy
315
A requirement for positive inotropic support (excluding digoxin) or serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation) within 1 year before screening
316
No currently unstable angina and/or uncontrolled cardiac arrhythmias
317
Significant cardiac disease within 6 months
318
No evidence of significant cardiac or pulmonary dysfunction
319
Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (ejection fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy; patients with significant history of cardiac disease will be evaluated by the investigator or his designee
320
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
321
Impaired cardiac function (defined futher in the protocol)
322
Known impaired cardiac function including any one of the following:
323
History of any of the following cardiac conditions:\r\n* Angina requiring treatment with long-acting nitrates\r\n* Angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration\r\n* Unstable angina within 90 days of visit 1\r\n* Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention
324
Significant cardiac disease
325
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
326
Evidence or history of significant cardiac disease
327
Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
328
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
329
Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation
330
Patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol
331
Patients with a serious cardiac condition within the past 6 months
332
Impaired cardiac function
333
Active cardiac disease including any of the following:\r\n* Angina pectoris that requires the use of anti-anginal medication\r\n* Ventricular arrhythmias except for benign premature ventricular contractions\r\n* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\r\n* Conduction abnormality requiring a pacemaker\r\n* Valvular disease with documented compromise in cardiac function\r\n* Symptomatic pericarditis
334
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
335
Active cardiac disease, defined as (but not limited to):
336
Have adequate cardiovascular function as defined by: i) a normal B-type natriuretic peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal electrocardiogram (ECG); if these criteria are not met, patients must have an echocardiogram or multigated acquisition cardiac scan (MUGA) showing an ejection fraction (EF) of 45% or greater with no more than \mild\ diastolic dysfunction and a BNP of < 200 pg/mL to be eligible
337
History of significant cardiac disorders:
338
Patients with impaired cardiac function or clinically significant cardiac disease:
339
Cardiac dysrhythmias;
340
Known impaired cardiac function or clinically significant cardiac disease
341
Patients with cardiac atrial or cardiac ventricular lymphoma involvement
342
DONOR: Adequate cardiac function by history and physical examination; those with a history of cardiac problems should undergo a stress evaluation or be evaluated by a cardiologist and deemed eligible to donate
343
Patients with cardiac insufficiency and a LVEF of < 40%; history of coronary artery disease or arrhythmia, which has required or requires ongoing treatment
344
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
345
Patients must have an electrocardiogram (EKG) that shows no significant abnormalities that are suggestive of active cardiac disease
346
Patients must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by a urologist; evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications
347
Significant cardiac events
348
Inadequate cardiac function
349
Cardiac involvement
350
Subject has ongoing cardiac arrhythmia that is Grade ? 2 or uncontrolled atrial fibrillation of any grade.
351
Impaired cardiac function or clinically significant cardiac diseases, history of arrhythmia (including ventricular fibrillation or torsade de pointes), bradycardia < 50 beats per minute (bpm), screening electrocardiogram (ECG) with prolonged corrected QT (QTc) or uncontrolled hypertension
352
Evidence of significant cardiac disease, for example: symptomatic cardiac heart failure (CHF, NYHA class 3), complete bundle branch block, significant atrial or ventricular tachyarrhythmias and any unstable cardiac arrhythmias requiring medication.
353
Patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
354
Patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
355
Cardiac abnormalities
356
Subject has ongoing cardiac arrhythmia that is Grade ? 2 or uncontrolled atrial fibrillation of any grade.
357
Left ventricular ejection fraction < 30%; Note: poor cardiac function predicts for cardiac morbidity, not cardiac mortality; therefore, a cardiology consultant may override the criteria for eligibility
358
Clinically significant cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded
359
Myocardial infarction in the previous 12 weeks. Active ischemia or any other uncontrolled cardiac condition such as angina pectoris, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or CHF.
360
Subject has ongoing cardiac arrhythmia (including atrial fibrillation) that is grade ?
361
Ongoing cardiac dysrhythmias
362
Acceptable cardiac function as indicated by protocol
363
History or evidence of cardiac risk.
364
Cardiac function: \r\n* ARM A: No evidence of uncontrolled heart failure or active angina\r\n* ARM B: No limitation
365
Cardiac function within normal range
366
History of cardiac disease
367
Impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease
368
Have cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin.
369
Active cardiac disease or a history of cardiac dysfunction.
370
Significant cardiac dysfunction:
371
Clinically significant cardiac disease or impaired cardiac function
372
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
373
No evidence of significant cardiac or pulmonary dysfunction
374
Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (ejection fraction less than 50%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy; patients will be evaluated by the investigator or his designee
375
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
376
Patients must not have known impaired cardiac function or clinically significant cardiac disease
377
serious cardiac arrhythmia.
378
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
379
Known cardiac disease which precludes their ability to receive planned treatments:\r\n * Angina pectoris that requires the use of anti-anginal medication\r\n * History of documented congestive heart failure\r\n * Serious cardiac arrhythmia requiring medication\r\n * Severe conduction abnormality\r\n * Valvular disease with documented cardiac function compromise; and\r\n * Uncontrolled hypertension defined as blood pressure (BP) that is consistently > 150/90 on antihypertensive therapy at the time of registration; (patients with hypertension that is well controlled on medication are eligible)
380
Uncontrolled cardiac arrhythmia
381
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
382
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
383
Cardiac involvement
384
Patient has any of the following cardiac abnormalities:
385
Serious uncontrolled cardiac arrhythmia.
386
Cardiac conditions
387
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever
388
Types of cardiac operations permitted:
389
Previous cardiac operation.
390
History of serious cardiac dysfunction
391
Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac\n             arrhythmia)
392
Unstable angina pectoris or cardiac arrhythmia
393
Cardiac arrhythmia requiring medication (does not include asymptomatic atrial fibrillation with controlled ventricular rate)
394
Patients who are over 40 years old or have had previous myocardial infarction greater than 6 months prior to study entry or have significant cardiac family history (coronary artery disease [CAD] or serious arrhythmias) will be required to have a negative or low probability cardiac stress test (for example, thallium stress test, stress multigated acquisition scan [MUGA], stress echo or exercise stress test) for cardiac ischemia within 8 weeks prior to registration
395
Cardiac abnormalities:
396
Patients with history of cardiac dysrhythmia
397
Patient's with any metallic cardiac implant
398
Any of the following cardiac criteria: CHF > Class II, cardiac ventricular arrhythmia requiring therapy, unstable angina or new-onset angina, QTcF interval >470ms, abnormal ECHO or MUGA at baseline (LVEF <50%).
399
History of cardiac disease
400
Impaired cardiac function
401
Patients with intra-cardiac defibrillators
402
Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrythmias classified as Lown III, IV or V.
403
Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy
404
No uncontrolled arrhythmias or symptomatic cardiac disease
405
The history or evidence of following cardiac abnormalities:
406
Abnormal cardiac valve morphology (>= Grade 2) documented by echocardiogram (ECHO)
407
Subjects with intra-cardiac defibrillators or permanent pacemakers
408
Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
409
History or evidence of cardiac risk
410
Recent malignant cardiac arrhythmias – all except sinus arrhythmia within 24 weeks prior to screening
411
Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
412
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
413
Known cardiac/cardiopulmonary disease
414
Impaired cardiac function or clinically significant cardiac diseases.
415
Unstable angina pectoris or cardiac arrhythmia;
416
History of cardiac disease
417
PART II: Subjects with evidence of cardiac toxicity and Q wave abnormalities at baseline ECG will not be allowed to participate
418
Known cardiac/cardiopulmonary disease
419
Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
420
Cardiac exclusions:
421
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
422
Patients with intra-cardiac defibrillators
423
Known significant uncontrolled cardiac arrhythmias
424
Left ventricular ejection fraction >= 40%, assessed within 3 months prior to study day 1, e.g. by multi gated acquisition (MUGA) scan or echocardiography, or other appropriate diagnostic modality and no clinical evidence of congestive heart failure; if the patient had anthracycline-based therapy since the most recent cardiac assessment, cardiac evaluation should be repeated if there is clinical or radiographical suspicion of cardiac dysfunction, or if the previous cardiac assessment was abnormal
425
Significant history of cardiac disease
426
Patients with cardiac arrhythmias must not be receiving anti-arrhythmic medication at time of study entry (or while on study).
427
Known, uncontrolled cardiac arrhythmias (except sinus arrhythmia) within the past 24 weeks
428
Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures.
429
Serious and inadequately controlled cardiac arrhythmia
430
Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol
431
Impaired cardiac function
432
History of heart failure or serious cardiac arrhythmia
433
History of significant cardiac dysfunction
434
Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
435
History of severe cardiac disease.
436
Significant history of cardiac disease
437
Clinically significant cardiac disease or impaired cardiac function
438
Normal cardiac function cardiac function by appropriate image testing.
439
Major cardiac disease
440
Has cardiac status as described in protocol
441
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
442
No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina\r\n* Patients who are over 40 years old or have had previous myocardial infarction greater than 6 months prior to study entry or have significant cardiac family history (coronary artery disease [CAD] or serious arrhythmias) will be required to have a negative or low probability cardiac stress test (for example, thallium stress test, stress multi-gated acquisition scan [MUGA], stress echocardiography [echo], or exercise stress test) for cardiac ischemia within 8 weeks prior to registration\r\n* An echocardiogram should be performed at baseline in all patients; ejection fraction (EF) from baseline echocardiogram must be within the institutional limits of normal as determined by the reading cardiologist; if the baseline cardiac stress test incorporates an echocardiogram, then this will not need to be done again at baseline
443
Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
444
Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
445
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
446
Certain cardiac abnormalities.
447
Serious cardiac arrhythmia requiring medication; this does not include atrial fibrillation
448
impaired cardiac function
449
Patients with intra-cardiac defibrillators or permanent pacemakers.
450
Cardiac metastases
451
Significant active cardiac disease within the previous 6 months:
452
History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
453
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
454
Normal Cardiac function
455
Abnormal cardiac stress testing within last 6 months
456
Active cardiac disease;
457
Current or uncontrolled cardiac disease
458
Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
459
Impaired cardiac function or clinically significant cardiac diseases
460
Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease
461
Symptomatic or uncontrolled cardiac failure or coronary artery disease
462
Subject has ongoing cardiac arrhythmia that is Grade ? 2 or uncontrolled atrial fibrillation of any grade.
463
All patients must have a stress test within 6 months of starting treatment showing no evidence of cardiac ischemia
464
Significant cardiac disease (i.e., left ventricular ejection fraction of < 50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months)
465
Active coronary disease with a positive cardiac stress test
466
Patients with unstable cardiac status including:
467
Serious accompanying cardiac disorder
468
Serious accompanying cardiac disorder.
469
Have a serious cardiac condition
470
History or evidence of cardiac abnormalities.
471
Presence of severe cardiac disease
472
Cardiac pacemakers
473
Have a cardiac pacemaker
474
Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease
475
History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal left ventricular (LV) function within 30 days of operation
476
Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia
477
Patients with documented advanced cardiac or renal disease
478
Severe cardiac disease
479
Patients with any known significant cardiac abnormality.
480
Patients who are status post revascularization procedures with satisfactory cardiac function are eligible
481
Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity
482
No known cardiac history (i.e., heart failure, myocardial infarction, or radiation-induced cardiac dysfunction)
483
Cardiac pacemaker
484
History of cardiac arrhythmias
485
Cardiac pacemaker
486
History of cardiac arrhythmia, controlled or uncontrolled, including ventricular and supraventricular arrhythmia
487
Impaired cardiac function including any of the following:
488
DONOR: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus brachycardia, sinus tachycardia or non?specific T wave changes) are ineligible for Triplex vaccination
489
Persons with acute cardiac or respiratory medical conditions, or who are pregnant/breastfeeding will not be eligible for participation
490
Cardiac ejection fraction < 30% on multi gated acquisition scan (MUGA) scan or cardiac echocardiogram (echo) or active symptomatic coronary artery disease; patients with cardiac disease should be evaluated with appropriate cardiac studies and/or cardiology consultation as clinically indicated
491
Unstable cardiac condition
492
Untreated or uncontrolled cardiovascular disease or other symptomatic cardiac dysfunction
493
Significant active cardiac disease within the previous 6 months, including:
494
Impaired cardiac function or clinically significant cardiac diseases
495
Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded.)
496
Impaired cardiac function or clinically significant cardiac diseases
497
Impaired cardiac function
498
Subject has a permanent cardiac pacemaker.
499
normal cardiac function
500
Patients with history or evidence of cardiac dysfunction
501
Normal baseline cardiac function based upon pre-operative evaluation at the physician's discretion
502
Known cardiac shunt
503
History of congestive cardiac failure or an electrocardiography (EKG) suggesting significant conduction defect, or myocardial ischemia, or active psychiatric disease requiring treatment that would interfere with the understanding or conduct of the study
504
Patients with known cardiac shunt
505
Unable to undergo MR imaging (e.g. cardiac device, metals, claustrophobia, etc.)
506
PATIENT: Patients with cardiac shunts or unstable cardiopulmonary conditions
507
Subject has any form of known cardiac arrhythmia
508
At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation
509
Cardiac disease (cardiac viability assessment)
510
Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
511
Normal baseline cardiac function based upon pre-operative evaluation
512
Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease – congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication)
513
Patients with cardiac shunts or unstable cardiopulmonary conditions.
514
Patients with cardiac shunts or congenital heart defects
515
Patient must not have serious and inadequately controlled cardiac arrhythmia
516
Impaired cardiac function or clinically significant cardiac disease
517
Patients with cardiac shunts
518
Patients with cardiac shunts
519
Patients with cardiac shunts
520
Known or suspected: cardiac shunts
521
History of cardiac arrhythmia requiring treatment
522
History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts
523
Severe cardiac disease
524
New (< 6 months) cardiac arrhythmia (electrocardiogram [EKG] should be performed within 2 weeks of starting IFN gamma)
525
History of significant cardiac disease or uncontrolled arrhythmias
526
Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions.
527
Serious cardiac arrhythmia (well-controlled atrial fibrillation is permitted) currently or within the past 6 months.
528
Impaired cardiac function including any one of the following:
529
Normal cardiac conduction and function (centrally read)
530
Abnormal cardiac status with any of the following:
531
History of cardiac dysfunction including any of the following:
532
Known, clinically important cardiac or respiratory disease