Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

Recruiting now · Not applicable

Conditions studied: Heart Diseases, Coronary Artery Disease, Coronary Artery Bypass Grafting

In brief

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 grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

Key facts

Study ID

NCT04124120

Run by

Weill Medical College of Cornell University

People needed

2300

Starts

2023-04-17

Expected to finish

2030-03-01

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• New York Presbyterian Queens — Queens, New York, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Pomona Valley Hospital Medical Center — Pomona, California, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Baystate Health — Springfield, Massachusetts, United States (enrolling)
• Yale University Hospital — New Haven, Connecticut, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Methodist Physicians Health — Omaha, Nebraska, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Englewood Health — Englewood, New Jersey, United States (enrolling)
• Newark Beth Israel Medical Center — Newark, New Jersey, United States (enrolling)
• The Valley Hospital — Ridgewood, New Jersey, United States (enrolling)
• NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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