REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women
Recruiting now · Phase 3
Conditions studied: Coronary Artery Disease
In brief
This is a research study in women 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.
Key facts
- Study ID
- NCT06399692
- Run by
- Weill Medical College of Cornell University
- People needed
- 600
- Starts
- 2024-09-16
- Expected to finish
- 2039-01-01
- Last updated by the study team
- 2025-10-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Female sex
- Patient is at least 18 years old.
- 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.
- Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.
You may not qualify if…
- ST-segment elevation MI within 3 days
- Cardiogenic shock
- Prior PCI within 1 year or any prior CABG anytime
- Planned hybrid revascularization (PCI after CABG or CABG after PCI)
- Planned single vessel revascularization (other than isolated left main disease)
- Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years
- 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
- 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
- Current participation in another investigational drug or device study that has not reached its primary endpoint
- Life-expectancy less than 3 years due to concomitant non-cardiac conditions
- 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.)
Where it is running
- Adventist Health Glendale — Glendale, California, United States (enrolling)
- Emory University — Atlanta, Georgia, United States (enrolling)
- Ascension St. Vincent Cardiovascular Research Institute — Carmel, Indiana, United States (enrolling)
- Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)
- Baptist Health Louisville — Louisville, Kentucky, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Englewood Hospital — Englewood, New Jersey, United States (enrolling)
- NewYork-Presbyterian Hospital - Queens — Flushing, New York, United States (enrolling)
- Icahn School of Medicine - Mount Sinai Morningside — New York, New York, United States (enrolling)
- Icahn School of Medicine - Mount Sinai Hospital — New York, New York, United States (enrolling)
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital — New York, New York, United States (enrolling)
- Weill Cornell Medicine / NYPH — New York, New York, United States (enrolling)
- Westchester Medical Center — Valhalla, New York, United States (enrolling)
- Duke University — Durham, North Carolina, United States (enrolling)
- Ohio State University — Columbus, Ohio, United States (enrolling)
- Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States (enrolling)
- Ascension Saint Thomas Hospital — Nashville, Tennessee, United States (enrolling)
- Baylor Scott and White — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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