REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women
RECHARGE:W
1 other identifier
interventional
600
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 coronary-artery-disease
Started Sep 2024
Longer than P75 for phase_3 coronary-artery-disease
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2024
CompletedFirst Posted
Study publicly available on registry
May 6, 2024
CompletedStudy Start
First participant enrolled
September 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2039
October 1, 2025
September 1, 2025
8.5 years
April 30, 2024
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2
Generic quality of life (QOL) will be assessed by utilizing the 12-item Short Form Survey (SF-12v2). The score ranges from 1-100, with higher scores indicating a better health status. The win ratio method will be utilized
5 years
Secondary Outcomes (1)
Time averaged change from baseline in disease-specific quality of life using the SAQ-OS
5 years
Other Outcomes (250)
Time-averaged changes in PROMIS-29 Scores
1 month, 3months, 6months, 12months and annually after procedure
Time-averaged changes in EQ5D-VAS Scores
1 month, 3months, 6months, 12months and annually after procedure
Time-averaged changes in PHQ Scores
1 month, 3months, 6months, 12months and annually after procedure
- +247 more other outcomes
Study Arms (2)
RECHARGE:Women - CABG
OTHERRECHARGE:Women - PCI
OTHERInterventions
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) 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
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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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 / NYPH
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
Weill Medical College of Cornell University
- PRINCIPAL INVESTIGATOR
Gregg S Stone, MD, FACC, MSCAI
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The researchers and most study personnel (including those from the QOL follow-up center and events assessors, clinical events committee and angiographic core laboratory) will be blinded to allocated treatment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2024
First Posted
May 6, 2024
Study Start
September 16, 2024
Primary Completion (Estimated)
March 15, 2033
Study Completion (Estimated)
January 1, 2039
Last Updated
October 1, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share