Randomization of Single vs Multiple Arterial Grafts

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease, Heart Diseases

In brief

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

Key facts

Study ID

NCT03217006

Run by

Weill Medical College of Cornell University

People needed

4300

Starts

2018-01-07

Expected to finish

2030-01-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary isolated CABG patients with disease of the left main coronary artery and/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…

• Age > 70 years
• Single graft
• Emergency operation
• Evolving myocardial infarction within 48 hours of surgery
• Left ventricular ejection fraction of < 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 reduce 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

• Baystate Health — Springfield, Massachusetts, United States (enrolling)
• Nebraska Heart Hospital — Lincoln, Nebraska, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States (enrolling)
• Icahn School of Medicine, Mount Sinai — New York, New York, United States (enrolling)
• Weil Cornell Medical College Department of Cardiothoracic Surgery — New York, New York, United States (enrolling)
• Lenox Hill Hospital (Northwell) — New York, New York, United States (enrolling)
• NewYork-Presbyterian Queens — New York, New York, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Allegheny General Hospital (Cardiovascular Institute) — Pittsburgh, Pennsylvania, United States (enrolling)
• Innsbruck (Medical University) Austria — Innsbruck, Austria (enrolling)
• Krankenhaus Nord Vienna North Hospital — Vienna, Austria (enrolling)
• MU Vienna Austria — Vienna, Austria (enrolling)
• Federal University of Sao Paulo — São Paulo, Brazil (enrolling)
• Hamilton General Hospital — Hamilton, Canada (enrolling)
• London Health Sciences Ontario Canada — London, Canada (enrolling)
• University Hospital of Montreal (CHUM) — Montreal, Canada (enrolling)
• University of Ottawa Heart Institute Canada — Ottawa, Canada (enrolling)
• Royal Victoria Hospital (McGill) — Québec, Canada (enrolling)
• Universite Laval Quebec (CRIUCPQ) Canada — Québec, Canada (enrolling)
• Sunnybrook Health Sciences Centre — Toronto, Canada (enrolling)
• Toronto General Hospital — Toronto, Canada (enrolling)
• St. Boniface General Hospital / WHRA — Winnipeg, Canada (enrolling)
• Fuwai Hospital — Beijing, China (enrolling)
• University of Colorado — Boulder, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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