PRE-DETERMINE Cohort Study

The PRE-DETERMINE Study is a prospective, multi-center study of patients with a history of
coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI)
or mild to moderate left ventricular dysfunction (LVEF 35-50%). Patients were enrolled at 136
sites where information on baseline demographics, clinical characteristics, pertinent past
medical history, lifestyle habits, cardiac test results, and medications were collected via
electronic data capture. Electrocardiograms along with a blood sample was also collected at
baseline, sent to central laboratories, and stored for future analyses. Contrast-enhanced
magnetic resonance imaging (CE-MRI) scans were collected on a subset of patients and
analyzed. Enrollment closed in November 2013 and patients are now being followed centrally by
the Clinical Coordinating Center via mail/phone to document interim non-fatal arrhythmic
events and cause-specific mortality. Questionnaires that inquire about intervening ICD
implantations, ICD therapies, cardiac arrest, and other pertinent cardiovascular endpoints
are mailed to participants every six months, and follow-up telephone calls are made to
non-responders. Study endpoints are being confirmed through review of medical records,
interviews with next-of-kin, and autopsy reports, if available.

Inclusion Criteria:

1. Evidence of Coronary Artery Disease (CAD) a or documented prior Myocardial Infarction.

2. 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.

3. 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.

4. Patients aged 18 years or above

1. 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)

2. 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

Exclusion Criteria:

1. 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).

2. Unexplained syncope

3. Current or planned implantable cardiac defibrillator (ICD)

4. Any condition other than cardiac disease that, in the investigator's judgment, would
seriously limit life expectancy (poor survival)

5. Metastatic cancer

6. Marked valvular heart disease requiring surgical intervention

7. Current or planned cardiac, renal or liver transplant

8. Current alcohol or drug abuse

9. Unwilling or unable to provide informed consent

10. LVEF <35% with Class II-IV CHF or LVEF <30%

11. Participation in a clinical trial where the active treatment arm is testing an agent
and/or intervention with known antiarrhythmic properties