PRE-DETERMINE Cohort Study
- Conditions
- Left Ventricular DysfunctionCoronary Artery DiseaseSudden Cardiac Death
- Registration Number
- NCT01114269
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 5764
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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
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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)
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MI can be documented in the following ways:
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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
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- 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).
- Unexplained syncope
- 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
- Current alcohol or drug abuse
- Unwilling or unable to provide informed consent
- LVEF <35% with Class II-IV CHF or LVEF <30%
- Participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation. Median follow-up estimated to be 10.7 years A definite sudden cardiac death (SCD) is defined as a death or fatal cardiac arrest occurring within 1 hour of symptom onset or the presence of autopsy consistent with SCD (e.g. acute coronary thrombosis). Probable SCD is defined as an unwitnessed death or death during sleep where the participant was observed to be symptom-free within the preceding 24 hours. Arrhythmic death is defined as the abrupt spontaneous collapse of circulation without antecedent circulatory or neurologic impairment. Deaths classified as non-arrhythmic are not included in the primary endpoint regardless of timing. Resuscitated ventricular fibrillation is defined as out-of-hospital cardiac arrests with documented VF and/or use of external electrical defibrillation for resuscitation.
- Secondary Outcome Measures
Name Time Method ICD Implantation Median follow-up estimated to be 10.7 years Non-Sudden or Arrhythmic Causes of Mortality Median follow-up estimated to be 10.7 years Competing causes of mortality in competing risk analyses.
ICD Shock Median follow-up estimated to be 10.7 years ICD therapies for ventricular arrhythmias over 200 BPMs will be added to the endpoint.
Total Cardiac Mortality Median follow-up estimated to be 10.7 years Total Mortality Median follow-up estimated to be 10.7 years
Trial Locations
- Locations (90)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Colorado Heart and Vascular
🇺🇸Denver, Colorado, United States
Wake Forest
🇺🇸Winston-Salem, North Carolina, United States
Orlando Regional Medical Center
🇺🇸Orlando, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
The Cardiac Center of Creighton University
🇺🇸Omaha, Nebraska, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
VA Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
Cardiovascular Consultants
🇺🇸Phoenix, Arizona, United States
University of Florida - Gainsville
🇺🇸Gainesville, Florida, United States
Alaska Heart Institute
🇺🇸Anchorage, Alaska, United States
Memorial Health System
🇺🇸Colorado Springs, Colorado, United States
Phoenix Heart, PLLC
🇺🇸Glendale, Arizona, United States
Beaver Medical Group/Clinical Care Research
🇺🇸Banning, California, United States
Bay Area Cardiology Associates, P.A.
🇺🇸Brandon, Florida, United States
Advocate Medical Group
🇺🇸Chicago, Illinois, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Georgia Heart Specialist
🇺🇸Covington, Georgia, United States
Hawthorn Medical Associates
🇺🇸North Dartmouth, Massachusetts, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Northeast Ohio Cardiovascular Specialists
🇺🇸Akron, Ohio, United States
NECCR Internal Medicine and Cardiology Associates, LLC
🇺🇸Fall River, Massachusetts, United States
New Mexico VA Healthcare Systems
🇺🇸Albuquerque, New Mexico, United States
Community Heart and Vascular
🇺🇸Anderson, Indiana, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Reliable Clinical Research
🇺🇸Miami, Florida, United States
Oklahoma City VA Medical Center Veterans Research and Education Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Foundation for Cardiovascular Research
🇺🇸Oklahoma City, Oklahoma, United States
Memphis VA Medical Center
🇺🇸Memphis, Tennessee, United States
The University of Kansas
🇺🇸Kansas City, Kansas, United States
McLaren Medical Center - Macomb
🇺🇸Mount Clemens, Michigan, United States
Advanced Heartcare, LLC
🇺🇸Bridgewater, New Jersey, United States
St. Joseph Regional Medical Center
🇺🇸Paterson, New Jersey, United States
Providence Health Center
🇺🇸Waco, Texas, United States
Gotham Cardiovascular
🇺🇸New York, New York, United States
Columbia University Health Center
🇺🇸New York, New York, United States
Tallahassee Research Institute, Inc.
🇺🇸Tallahassee, Florida, United States
Cardiovascular Associates Virginia Beach
🇺🇸Virginia Beach, Virginia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Advocate Medical Group - Heart and Vascular of IL
🇺🇸Chicago, Illinois, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Baystate Cardiology
🇺🇸Springfield, Massachusetts, United States
Northstate Clinical Research
🇺🇸Lenoir, North Carolina, United States
Northwest Ohio Cardiology Consultants/The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Northeast Georgia Heart Center, P.C.
🇺🇸Gainesville, Georgia, United States
Maine Research Associates
🇺🇸Auburn, Maine, United States
Primary Care Cardiology Research
🇺🇸Ayer, Massachusetts, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
St. Elizabeth Medical Center - Hotvedt
🇺🇸Utica, New York, United States
Minneapolis VA Medical Center
🇺🇸Minneapolis, Minnesota, United States
Cardiology Associates of Palm Beach - West Palm Beach
🇺🇸West Palm Beach, Florida, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Albany Associates Cardiology
🇺🇸Albany, New York, United States
Velella Research
🇺🇸Sarasota, Florida, United States
Glacier View Cardiology
🇺🇸Kalispell, Montana, United States
Buffalo General Hospital/Kaleida Health
🇺🇸Buffalo, New York, United States
Palm Beach Gardens Research Center
🇺🇸Palm Beach Gardens, Florida, United States
Leonard J. Chabert Medical Center
🇺🇸Houma, Louisiana, United States
Maine Research Associates - Lewiston
🇺🇸Lewiston, Maine, United States
Transcatheter Medical, Inc. Centro Cardiovascular de Caguas y del Caribe
🇵🇷Rio Piedras, Puerto Rico
St. Luke's Bethlehem
🇺🇸Bethlehem, Pennsylvania, United States
Pinehurst Medical Clinic, Inc.
🇺🇸Pinehurst, North Carolina, United States
Mississauga Clinical Research Centre
🇨🇦Mississauga, Ontario, Canada
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Winthrop-University Hospital
🇺🇸Mineola, New York, United States
Eastern Carolina Cardiovascular
🇺🇸Elizabeth City, North Carolina, United States
Sanford Cardiology
🇺🇸Sanford, North Carolina, United States
Cardiovasular Research of Knoxville
🇺🇸Knoxville, Tennessee, United States
Asheville Cardiology Associates
🇺🇸Asheville, North Carolina, United States
St. Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
North Ohio Research, Ltd.
🇺🇸Elyria, Ohio, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Non-Invasive Cardiovascular PA
🇺🇸Houston, Texas, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Black Hills Cardiovascular Research
🇺🇸Rapid City, South Dakota, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Mercy Medical Associates
🇺🇸Fairfield, Ohio, United States
Doylestown Cardiology Associates
🇺🇸Doylestown, Pennsylvania, United States
Consultants in Cardiovascular Medicine
🇺🇸Melrose Park, Illinois, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Oakwood Hospital & Medical Center
🇺🇸Dearborn, Michigan, United States
Mid-Valley Cardiology
🇺🇸Kingston, New York, United States
Carolina Cardiology Associates
🇺🇸Rock Hill, South Carolina, United States