PRE-DETERMINE Cohort Study

Prior treatment

• Current alcohol or drug abuse

Other illness

• History of cardiac arrest or spontaneous or inducible sustained VT (15 beats or more at a rate of 120 BPM or greater - the occurrence of cardiac arrest or spontaneous VT in the setting of an acute MI is not considered an exclusion).
• Current or planned implantable cardiac defibrillator (ICD)
• Any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival)
• Metastatic cancer
• Marked valvular heart disease requiring surgical intervention
• Current or planned cardiac, renal or liver transplant

Lab values

• LVEF \<35% with Class II-IV CHF or LVEF \<30%

Other

• Unexplained syncope
• Unwilling or unable to provide informed consent
• Participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties

• Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction.
• LVEF \>35% by any current standard evaluation technique (e.g.,) echocardiogram, MUGA, angiography). 2.1. Patients who have an LVEF between 30-35% and NYHA Class I heart failure who do not have history of ventricular tachyarrhythmias,or inducible ventricular tachycardia during electrophysiological (EP) testing can be enrolled.
• If documented prior MI is not present, evidence of mild-moderate systolic Left Ventricular Dysfunction with an EF \>35- ≤50% as measured by any current standard screening technique (e.g.,echocardiogram, MUGA, angiography) must be present.
• Patients aged 18 years or above
  • CAD will be defined as evidence of one of the following two (2) criteria:
  • Significant stenosis of a major epicardial vessel (\>50% proximal or 70% distal) by coronary angiography
  • Prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery)
  • MI can be documented in the following ways:
  • From the MI hospitalization: Detection of a rise and fall of cardiac biomarkers \> 99th percentile of lab (e.g., CPK elevation or Troponin at least \> two times the upper limit of normal) together with myocardial ischemia with at least one of the following:
  • Symptoms of Ischemia
  • ECG changes indicative of new ischemia (new ST-T changes or new LBBB)
  • Development of pathological Q waves
  • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
  • If no report from the MI hospitalization is available, prior MI can be met by either of the following:
  • Development of pathological Q waves
  • Imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischaemic cause