REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Minorities
Start Date
10/2/2024
Completion Date
1/1/2039
Summary
This is a research study in minorities to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.
Detailed Description
The RECHARGE: Minorities Trial is a multicenter, 1:1 randomized, open-label superiority trial. Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Coronary artery bypass grafting
Percutaneous coronary intervention
Conditions
Locations
Adventist Health Glendale
Glendale, California 91206
United States
Emory University
Atlanta, Georgia 30322
United States
Ascension St. Vincent Cardiovascular Research Institute
Carmel, Indiana 46290
United States
Baptist Health Lexington
Lexington, Kentucky 40503
United States
Baptist Health Louisville
Louisville, Kentucky 40207
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Englewood Hospital
Englewood, New Jersey 07631
United States
NewYork-Presbyterian Hospital - Queens
Flushing, New York 11355
United States
Icahn School of Medicine - Mount Sinai Morningside
New York, New York 10025
United States
Icahn School of Medicine - Mount Sinai Hospital
New York, New York 10029
United States
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
New York, New York 10032
United States
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York 10065
United States
Westchester Medical Center
Valhalla, New York 10595
United States
Duke University
Durham, North Carolina 27710
United States
Ohio State University
Columbus, Ohio 43210
United States
Methodist Le Bonheur Healthcare
Memphis, Tennessee 38104
United States
Ascension Saint Thomas Hospital
Nashville, Tennessee 37205
United States
Baylor Scott and White
Dallas, Texas 75246
United States