[c09aa8]: / clusters / 9knumclustersv2 / clust_1987.txt

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Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
Patients with a history of coronary artery disease may be included if they have had a normal cardiac stress test within days of enrollment
Normal cardiac stress test for patients over years of age
Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult; patients with reversible ischemic changes on cardiac stress test
Presence of aneurisms of the ascending aorta or aortic stress.
Myocardial infarction within months of course day (CD); subjects with a history of myocardial infarction between and months prior to CD who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
Since IL- is administered following cell infusion:\r\n* Patients will be excluded if they have a history of clinically significant electrocardiogram (ECG) abnormalities, symptoms of cardiac ischemia with evidence of ischemia on a cardiac stress test (stress thallium, stress multigated acquisition [MUGA], dobutamine echocardiogram or other stress test)\r\n* Similarly, patients with a baseline left ventricular ejection fraction (LVEF) < percent (%) will be excluded\r\n* Patients with ECG results of any conduction delays (PR interval > ms, corrected QT [QTC] > ms), sinus bradycardia (resting heart rate < beats per minute), sinus tachycardia (heart rate > beats per minute) will be evaluated by a cardiologist prior to starting the trial; patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as > premature ventricular contractions [PVCs] per minute), ventricular tachycardia or rd degree heart block will be excluded from the study unless cleared by a cardiologist\r\n* Patients with pulmonary function test abnormalities as evidenced by a forced expiratory volume in (FEV) / forced vital capacity (FVC) < % of predicted for normality will be excluded
Subjects years of age and older must also have a negative stress cardiac test (i.e. EKG stress test, stress thallium, dobutamine echocardiogram or other stress test that will rule out cardiac ischemia). Stress test may be required of subjects less than years of age if warranted by family history or risk factors by the treating investigator.
Since IL- is administered following cell infusion:\r\n* Patients will be excluded if they have a history of clinically significant electrocardiogram (ECG) abnormalities, symptoms of cardiac ischemia with evidence of ischemia on a cardiac stress test (stress thallium, stress multigated acquisition [MUGA], dobutamine echocardiogram or other stress test)\r\n* Similarly, patients with a baseline left ventricular ejection fraction (LVEF) < % will be excluded.\r\n* Patients with ECG results of any conduction delays (PR interval > ms, corrected QT [QTC] > ms), sinus bradycardia (resting heart rate < beats per minute), sinus tachycardia (heart rate > beats per minute) will be evaluated by a cardiologist prior to starting the trial; patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as > premature ventricular contractions [PVCs] per minute), ventricular tachycardia or rd degree heart block will be excluded from the study unless cleared by a cardiologist\r\n* Patients with pulmonary function test abnormalities as evidenced by a (forced expiratory volume [FEV]/forced vital capacity [FVC ] < % of predicted for normality will be excluded
Cardiac stress test within past months without evidence of reversible ischemia
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Patients with electrocardiogram (EKG) within 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
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 %; a cardiac stress test is required for all patients greater than years old; a cardiac stress test may also be performed for any clinical concern; patients with cardiac ischemia are not eligible
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 months of study entry
Subjects must be considered appropriate candidates for high dose (HD) IL- by one of the treating investigators listed on the protocol; HD IL- candidacy evaluation is per institutional guidelines at each site and should include a dobutamine stress echocardiogram or equivalent; subjects with a positive stress test for cardiac ischemia would be excluded from this trial
Cardiac testing with either exercise stress test or thallium stress test, within months of start of the first treatment day; atrial fibrillation that is rate controlled is allowed; note the first treatment day is about weeks before the first IL- treatment day; if a cardiologists evaluation determines that this is superfluous based on other assessments, then this may be omitted
Since IL- is administered following cell infusion:\r\n* Patients will be excluded if they have a history of clinically significant electrocardiogram (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) < % on a cardiac stress test (stress thallium, stress multi gated acquisition scan [MUGA], dobutamine echocardiogram, or other stress test)\r\n* Similarly, patients who are >= years old with a baseline LVEF < % will be excluded\r\n* Patients with ECG results of any conduction delays (PR interval > ms, corrected QT interval [QTC] > ms), sinus bradycardia (resting heart rate < beats per minute), sinus tachycardia (heart rate > beats per minute) will be evaluated by a cardiologist prior to starting the trial; patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as > premature ventricular contractions [PVCs] per minute), ventricular tachycardia, third (rd) degree heart block will be excluded from the study unless cleared by a cardiologist\r\n* Patients with pulmonary function test abnormalities as evidenced by a forced expiration volume in one second (FEV)/forced vital capacity (FVC) < % of predicted for normality will be excluded
Patients who are greater than age , or who have a history of coronary artery disease, will be required to undergo cardiac stress testing within months of screening and will be excluded if there is evidence of reversible ischemia
For patients designated to be treated on Group : cardiac ejection fraction >= %; for patients with significant risk factors for coronary artery disease (Framingham risk score > %), a cardiac stress test is recommended
LVEF (left ventricular end diastolic function) of >= %; LVEF between % and % must have negative stress test with increase in ejection fraction (EF) of - points with stress
Myocardial infarction within year of study entry; subjects with a history of myocardial infarction between and months prior to study entry who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
Patients with a history of coronary artery disease may be included if they have had a normal stress test within days of enrollment
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 month of lymphodepletion
Patients with chronic kidney disease who are on chronic renal replacement therapy are allowed; other tests, such as pulmonary function tests, cardiac echocardiogram or stress test, will be performed if clinically indicated
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 months of lymphodepletion (Turnstile II)
Adequate cardiac function (adequate perfusion; no ischemia) on thallium (or technetium [Tc]) stress test
A stress cardiac test (stress thallium, stress multigated acquisition [MUGA] scan, dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) within months of lymphodepletion (Turnstile II)
Since IL- is administered following cell infusion:\r\n* Patients will be excluded if they have a history of clinically significant electrocardiogram (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) < % on a cardiac stress test (stress thallium, stress multigated acquisition scan [MUGA], dobutamine echocardiogram, or other stress test) \r\n* Similarly, patients who are years old with a baseline LVEF < % will be excluded\r\n* Patients with ECG results of any conduction delays (PR interval > ms, corrected QT interval [QTC] > ms), sinus bradycardia (resting heart rate < beats per minute), sinus tachycardia (heart rate [HR] > beats per minute) will be evaluated by a cardiologist prior to starting the trial; patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as > premature ventricular contractions [PVCs] per minute), ventricular tachycardia, third (rd) degree heart block will be excluded from the study unless cleared by a cardiologist\r\n* Patients with pulmonary function test abnormalities as evidenced by a forced ejection volume in second (FEV)/forced vital capacity (FVC) < % of predicted for normality will be excluded
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 months of lymphodepletion (Turnstile II - Chemotherapy/Cell Infusion-Inclusion Criteria)
Normal/negative cardiac stress testing with myocardial perfusion imaging OR cardiac catheterization with non-significant angiogram findings reviewed by a cardiology consultant (dose level and >= years old)
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 % will be excluded.
Presence of aneurisms of the ascending aorta or aortic stress
Normal cardiac function; patients who have a history of heart disease, or who are over the age of years must have a normal cardiac stress test within the prior days
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 months of study entry
Patients with electrocardiogram (EKG) within 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
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 months of lymphodepletion in those over years of age or with a known history coronary artery disease
Ejection fraction (EF) by multigated acquisition scan (MUGA) or -dimensional (-D) echocardiogram within institution normal limits; in case of low EF, the subject may remain eligible after a stress echocardiogram is performed if the EF is more than % and if the increase in EF with stress is estimated at % or more
Ejection fraction (EF) by multiple gated acquisition scan (MUGA) or -dimensional (D) echocardiogram within institution normal limits; in case of low EF, the subject may remain eligible after a stress echocardiogram is performed if the EF is more than % and if the increase in EF with stress is estimated at % or more
Active coronary artery disease (defined as unstable angina or a positive cardiac stress test)
Since IL- is administered following cell infusion:\r\n* Patients will be excluded if they have a history of clinically significant electrocardiogram (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) < % on a cardiac stress test (stress thallium, stress multi gated acquisition [MUGA] scan, dobutamine echocardiogram, or other stress test)\r\n* Similarly, patients who are years old with a baseline LVEF < % will be excluded\r\n* Patients with ECG results of any conduction delays (PR interval > ms, corrected QT interval [QTC] > ms), sinus bradycardia (resting heart rate < beats per minute), sinus tachycardia (heart rate > beats per minute) will be evaluated by a cardiologist prior to starting the trial; patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as > premature ventricular contractions [PVCs] per minute), ventricular tachycardia, rd degree heart block will be excluded from the study unless cleared by a cardiologist\r\n* Patients with pulmonary function test abnormalities as evidenced by a forced expiratory volume of the lung in second (FEV)/forced vital capacity (FVC) < % of predicted for normality will be excluded
A functional cardiac test (e.g., stress treadmill, stress thallium, multigated acquisition scan (MUGA), dobutamine echocardiogram) to rule out cardiac ischemia within months prior to lymphodepletion is required for all patients
Since interleukin (IL)- is administered following cell infusion: \r\n* Patients will be excluded if they have a history of clinically significant electrocardiogram (ECG) abnormalities, symptoms of cardiac ischemia or arrhythmias and have a left ventricular ejection fraction (LVEF) < % on a cardiac stress test (stress thallium, stress multigated acquisition [MUGA], dobutamine echocardiogram, or other stress test) \r\n* Similarly, patients who are years old with a baseline LVEF < % will be excluded\r\n* Patients with ECG results of any conduction delays (PR interval > ms, corrected QT interval [QTC] > ms), sinus bradycardia (resting heart rate < beats per minute), sinus tachycardia (heart rate [HR] > beats per minute) will be evaluated by a cardiologist prior to starting the trial; patients with any arrhythmias, including atrial fibrillation/atrial flutter, excessive ectopy (defined as > premature ventricular contractions [PVCs] per minute), ventricular tachycardia, rd degree heart block will be excluded from the study unless cleared by a cardiologist\r\n* Patients with pulmonary function test abnormalities as evidenced by a forced expiratory volume in second (FEV)/forced vital capacity (FVC) < % of predicted for normality will be excluded
Myocardial infarction within months of cycle one, day one (CD); subjects with a history of myocardial infarction between and months prior to CD who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
Evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which would likely increase the risks of participating in the study. The specific type of stress test will be selected at the PI's discretion.
For patients with history of major coronary artery disease in the judgment of the responsible physician, a cardiac stress test (either exercise or pharmacologic) that demonstrates clinically significant abnormalities when performed within weeks of first dose of study drug
Cardiac ejection fraction >= % (multigated acquisition [MUGA] or echocardiogram); for patients with significant risk factors for coronary artery disease (CAD) (including family history, hypertension, and/or dyslipidemia), or age > , stress echo or stress thallium testing is required
Patients who are over years old or have had previous myocardial infarction greater than 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 weeks prior to registration
Myocardial infarction within months of cycle day (CD); subjects with a history of myocardial infarction between and months prior to CD who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
Cardiac stress test (e.g., stress thallium scan, stress echocardiography) with normal results if patient is suspected to have coronary artery disease.
No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than months prior to entry, serious cardiac arrhythmias, or unstable angina\r\n* Patients who are over years old or have had previous myocardial infarction greater than 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 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
Abnormal cardiac stress testing within last months
All patients must have a stress test within months of starting treatment showing no evidence of cardiac ischemia
Active coronary disease with a positive cardiac stress test
Self-report of moderate to high levels of stress using the Perceived Stress Scale
Any contraindication to cardiac stress testing
History of active coronary disease unless a cardiac stress test showing no reversible ischemia and normal left ventricular (LV) function within days of operation
History of Post-traumatic Stress Disorder
Endorse moderate stress or distress as measured by a score of or above on the a distress thermometer and an adapted thermometer of stress;
Cancer patients who are scheduled for (perfusion) nuclear stress testing using regadenoson as stress agent
Patients with a history of coronary artery disease must have had a normal stress test within days of starting IFN gamma