PRE-DETERMINE Cohort Study

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Apr 29, 2010

Keywords

ClinConnect Summary

The PRE-DETERMINE Cohort Study is a research project looking at patients who have coronary artery disease (CAD) and may be at risk for sudden cardiac death (SCD). The study aims to find out if certain biological markers and heart monitoring tests (like ECGs) can help predict the risk of life-threatening heart rhythms in people with CAD and a specific level of heart function (left ventricular ejection fraction, or LVEF between 30-50%). By identifying these markers, researchers hope to improve how we can spot individuals who are at risk and potentially save lives by better targeting treatments, such as implantable defibrillators.

To be eligible for the study, participants need to be at least 18 years old and have documented evidence of CAD or a history of heart attacks. They should also have a heart function score (LVEF) greater than 35%. However, patients with certain conditions, like a history of severe heart rhythm problems or those currently using a heart defibrillator, cannot participate. Those who join the study will contribute to important research that could lead to better understanding and prevention of sudden cardiac death in patients with heart disease.

Gender

ALL

Eligibility criteria

• 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