REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women
NCT ID: NCT06399692
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2024-09-16
2039-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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RECHARGE:Women - CABG
Coronary artery bypass grafting (CABG)
Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.
RECHARGE:Women - PCI
Percutaneous coronary intervention (PCI)
Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart
Interventions
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Coronary artery bypass grafting (CABG)
Coronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.
Percutaneous coronary intervention (PCI)
Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart
Eligibility Criteria
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Inclusion Criteria
2. Patient is at least 18 years old.
3. Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.
Exclusion Criteria
2. Cardiogenic shock
3. Prior PCI within 1 year or any prior CABG anytime
4. Planned hybrid revascularization (PCI after CABG or CABG after PCI)
5. Planned single vessel revascularization (other than isolated left main disease)
6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years
7. Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization
8. Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome
9. Current participation in another investigational drug or device study that has not reached its primary endpoint
10. Life-expectancy less than 3 years due to concomitant non-cardiac conditions
11. Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Gregg S Stone, MD, FACC, MSCAI
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Adventist Health Glendale
Glendale, California, United States
Emory University
Atlanta, Georgia, United States
Ascension St. Vincent Cardiovascular Research Institute
Carmel, Indiana, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Baptist Health Louisville
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Englewood Hospital
Englewood, New Jersey, United States
NewYork-Presbyterian Hospital - Queens
Flushing, New York, United States
Icahn School of Medicine - Mount Sinai Morningside
New York, New York, United States
Icahn School of Medicine - Mount Sinai Hospital
New York, New York, United States
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
New York, New York, United States
Weill Cornell Medicine / NYPH
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Duke University
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Methodist Le Bonheur Healthcare
Memphis, Tennessee, United States
Ascension Saint Thomas Hospital
Nashville, Tennessee, United States
Baylor Scott and White
Dallas, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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23-11026800 - 1
Identifier Type: -
Identifier Source: org_study_id
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