[c09aa8]: / clusters / ordered9kclusters / clust_2004.txt

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Patients who have the following risk factors are considered to be at increased risk for cardiac toxicity and must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution’s lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* A New York Heart Association (NYHA) classification of II controlled with treatment\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart.\r\n* History of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded)
No clinically significant cardiac arrhythmias, stroke or myocardial infarction within 6 months prior to enrollment
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.
Ischemic cardiac event including myocardial infarction within 3 months prior to first dose
Myocardial infarction within 6 months of course 1 day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 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
Patients must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution’s lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months prior to registration if they have any of the following risk factors for cardiac toxicities:\r\n* A New York Heart Association (NYHA) classification of II controlled with treatment \r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 12 months prior to registration\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* Prior history of other significant impaired cardiac function
Significant cardiac disease such as recent myocardial infarction
Patient has any unstable or uncontrolled medical condition that would make it potentially unsafe to undergo TURBT including a previous stroke or myocardial infarction within 6 months
Ischemic cardiac event including myocardial infarction within 3 months prior to first dose;
Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction =< 6 months prior to study entry
Patients who have the following risk factors are considered to be at increased risk for cardiac toxicities, and must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution’s lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* A New York Heart Association (NYHA) classification of II controlled with treatment\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)
History of an ischemic cardiac event including myocardial infarction within 3 months of study entry
Significant cardiac abnormalities such as:\r\n* Myocardial infarction within 3 months of course 1 day 1 (C1D1); (subjects with a history of myocardial infarction between 3 and 12 months prior to C1D1 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);\r\n* An electrocardiogram (ECG) recorded at screening showing evidence of cardiac ischemia (ST depression of >= 2 mm, measured from isoelectric line to the ST segment); if in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not coronary artery disease (CAD) is present;\r\n* Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class III to IV definitions and/or ejection fraction < 30% by multigated acquisition scan (MUGA) scan or < 50% by echocardiogram and/or magnetic resonance imaging (MRI)
Myocardial infarction within 1 year of study entry; subjects with a history of myocardial infarction between 6 and 12 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
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
History of cardiac infarction within the past 12 months prior to the start of study treatment
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
Patients experiencing a cardiac events (acute coronary syndrome, myocardial infarction, or ischemia) within the 3 months prior to accrual
Prior myocardial infarction within one year of study entry
Known history of Torsade de Pointes, unstable cardiac arrhythmia or proarrhythmic conditions, or a history of recent myocardial infarction within 90 days of study entry.
History of myocardial infarction within 6 months with a residual arrhythmia that in the opinion of the investigator, increases the risk of ventricular arrhythmia
Significant cardiac disease such as recent myocardial infarction
Myocardial infarction, cardiac arrest or cardiac failure within 1 year before screening/baseline visit;
Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
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
Subjects with a history of myocardial infarction or uncontrolled cardiac dysfunction\n during the previous 6 months
Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of randomization
Left ventricular ejection fraction (LVEF) < lower limit of normal (LLN) per institutional guidelines, or <55%, if threshold for normal not otherwise specified by institutional guidelines, for patients with the following risk factors: Prior treatment with anthracyclines; Prior treatment with trastuzumab; Prior central thoracic RT, including exposure of heart to therapeutic doses of ionizing RT; History of myocardial infarction within 6-12 months prior to start of IPs; Prior history of other significant impaired cardiac function
Patients with any of 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* A NYHA classification of II controlled with treatment\r\n* Prior history of impaired cardiac function
Myocardial infarction within 6 months of cycle one, day one (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 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
History of myocardial infarctions or cardiac stent placement less than 1 year before recruitment into the study
History or clinical signs of myocardial infarction within 1 year prior to study entry
Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction =< 6 months prior to study entry
Patients who have the following risk factors are considered to be at increased risk for cardiac toxicities; these patients should have increased monitoring:\r\n* Prior treatment with anthracyclines\r\n* Prior treatment with trastuzumab\r\n* A New York Heart Association classification of II controlled with treatment\r\n* Prior central thoracic radiation therapy (RT), including RT to the heart\r\n* History of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)
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; patients who are over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemia
Echocardiogram should be done within 7 days of starting therapy if there are cardiac risk factors (e.g., history of hypertension or of myocardial infarction)
Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment
Hemodynamically unstable patients (not in cardiogenic shock or having an acute myocardial infarction [MI])
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
Myocardial infarction within 6 months of cycle 1 day 1 (C1D1); subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 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
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
Myocardial infarction within one year prior to study entry.
Significant cardiac disease (i.e., left ventricular ejection fraction of < 50%, unstable angina, placement of cardiac stents and myocardial infarction within previous 6 months)
Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
History of an ischemic cardiac event including myocardial infarction within 3 months of study entry
Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
Patients with a history of myocardial infarction are eligible if the event occurred > 6 months prior to entry
History or clinical signs of myocardial infarction within 1 year of study entry