Status:
RECRUITING
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
New York Presbyterian Hospital
Sunnybrook Health Sciences Centre
Conditions:
Heart Diseases
Coronary Artery Disease
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grfating (SAG). The speci...
Detailed Description
ROMA:Women will leverage the infrastructure and the existing women population of the ROMA trial. ROMA:Women has two key Aims. In Aim 1, the investigators will compare major adverse cardiac and cerebro...
Eligibility Criteria
Inclusion
- Women patients ≥18 years old.
- Isolated coronary artery bypass grafting.
- Primary (first time) cardiac surgery procedure.
- Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
Exclusion
- Male gender
- Single graft
- Emergency operation
- Myocardial infarction within 72 hours of surgery
- Left ventricular ejection fraction \< 35%
- Any concomitant cardiac or non-cardiac procedure
- Previous cardiac surgery
- Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.
- Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
- Anticipated need for coronary thrombo-endarterectomy
- Planned hybrid revascularization
Key Trial Info
Start Date :
April 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04124120
Start Date
April 17 2023
End Date
March 1 2030
Last Update
April 6 2025
Active Locations (141)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
3
University of California, San Francisco
San Francisco, California, United States, 94118
4
University of Colorado
Aurora, Colorado, United States, 80045