PRE-DETERMINE Cohort Study
PRE-DETERMINE Cohort Study
This is a prospective, multi-center cohort 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%). The primary objective of this study
 is to determine whether biologic markers and ECGs can be utilized to advance SCD risk
 prediction in patients with CHD and LVEF>30-35%. The overarching goal of the study is to
 identify a series of markers that alone or in combination specifically predict risk of
 arrhythmic death as compared to other causes of mortality among this at risk population of
 coronary heart disease (CHD) patients with preserved left ventricular ejection fraction
 (LVEF> 30-35%). If biologic or ECG markers are identified that can specifically predict risk
 of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to
 identify those at risk. The public health impact of identifying markers could be quite
 substantial, leading to more efficient utilization of ICDs and advances in our understanding
 of mechanisms underlying SCD.
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 135
 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