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ACTIVE NOT RECRUITING
NCT01114269

PRE-DETERMINE Cohort Study

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Official title: PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

5764

Start Date

2007-07

Completion Date

2026-11

Last Updated

2025-10-07

Healthy Volunteers

No

Locations (90)

Alaska Heart Institute

Anchorage, Alaska, United States

Phoenix Heart, PLLC

Glendale, Arizona, United States

Cardiovascular Consultants

Phoenix, Arizona, United States

Beaver Medical Group/Clinical Care Research

Banning, California, United States

Memorial Health System

Colorado Springs, Colorado, United States

Colorado Heart and Vascular

Denver, Colorado, United States

Bay Area Cardiology Associates, P.A.

Brandon, Florida, United States

University of Florida - Gainsville

Gainesville, Florida, United States

Reliable Clinical Research

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Florida Hospital

Orlando, Florida, United States

Orlando Regional Medical Center

Orlando, Florida, United States

Palm Beach Gardens Research Center

Palm Beach Gardens, Florida, United States

Velella Research

Sarasota, Florida, United States

Tallahassee Research Institute, Inc.

Tallahassee, Florida, United States

Cardiology Associates of Palm Beach - West Palm Beach

West Palm Beach, Florida, United States

Georgia Heart Specialist

Covington, Georgia, United States

Northeast Georgia Heart Center, P.C.

Gainesville, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Advocate Medical Group

Chicago, Illinois, United States

Advocate Medical Group - Heart and Vascular of IL

Chicago, Illinois, United States

Consultants in Cardiovascular Medicine

Melrose Park, Illinois, United States

Community Heart and Vascular

Anderson, Indiana, United States

Iowa Heart Center

West Des Moines, Iowa, United States

The University of Kansas

Kansas City, Kansas, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Leonard J. Chabert Medical Center

Houma, Louisiana, United States

Maine Research Associates

Auburn, Maine, United States

Maine Research Associates - Lewiston

Lewiston, Maine, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Primary Care Cardiology Research

Ayer, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

NECCR Internal Medicine and Cardiology Associates, LLC

Fall River, Massachusetts, United States

Hawthorn Medical Associates

North Dartmouth, Massachusetts, United States

Baystate Cardiology

Springfield, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Oakwood Hospital & Medical Center

Dearborn, Michigan, United States

McLaren Medical Center - Macomb

Mount Clemens, Michigan, United States

Michigan Heart

Ypsilanti, Michigan, United States

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

University of Missouri Health Care

Columbia, Missouri, United States

Glacier View Cardiology

Kalispell, Montana, United States

The Cardiac Center of Creighton University

Omaha, Nebraska, United States

Advanced Heartcare, LLC

Bridgewater, New Jersey, United States

St. Joseph Regional Medical Center

Paterson, New Jersey, United States

New Mexico VA Healthcare Systems

Albuquerque, New Mexico, United States

Albany Associates Cardiology

Albany, New York, United States

Maimonides Medical Center

Brooklyn, New York, United States

Buffalo General Hospital/Kaleida Health

Buffalo, New York, United States

Jamaica Hospital Medical Center

Jamaica, New York, United States

Mid-Valley Cardiology

Kingston, New York, United States

Winthrop-University Hospital

Mineola, New York, United States

Gotham Cardiovascular

New York, New York, United States

Columbia University Health Center

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

St. Elizabeth Medical Center - Hotvedt

Utica, New York, United States

Asheville Cardiology Associates

Asheville, North Carolina, United States

Eastern Carolina Cardiovascular

Elizabeth City, North Carolina, United States

Northstate Clinical Research

Lenoir, North Carolina, United States

Pinehurst Medical Clinic, Inc.

Pinehurst, North Carolina, United States

Sanford Cardiology

Sanford, North Carolina, United States

Wake Forest

Winston-Salem, North Carolina, United States

Northeast Ohio Cardiovascular Specialists

Akron, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

North Ohio Research, Ltd.

Elyria, Ohio, United States

Mercy Medical Associates

Fairfield, Ohio, United States

Northwest Ohio Cardiology Consultants/The Toledo Hospital

Toledo, Ohio, 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

Abington Memorial Hospital

Abington, Pennsylvania, United States

St. Luke's Bethlehem

Bethlehem, Pennsylvania, United States

Doylestown Cardiology Associates

Doylestown, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

AnMed Health

Anderson, South Carolina, United States

VA Medical Center - Charleston

Charleston, South Carolina, United States

Carolina Cardiology Associates

Rock Hill, South Carolina, United States

Black Hills Cardiovascular Research

Rapid City, South Dakota, United States

Cardiovasular Research of Knoxville

Knoxville, Tennessee, United States

Memphis VA Medical Center

Memphis, Tennessee, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

Non-Invasive Cardiovascular PA

Houston, Texas, United States

Providence Health Center

Waco, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Cardiovascular Associates Virginia Beach

Virginia Beach, Virginia, United States

University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Mississauga Clinical Research Centre

Mississauga, Ontario, Canada

Transcatheter Medical, Inc. Centro Cardiovascular de Caguas y del Caribe

Rio Piedras, Puerto Rico