Randomization of Single vs Multiple Arterial Grafts (NCT03217006)
Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Colorado — Boulder, Colorado
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
- Single arterial graft (PROCEDURE)
- Multiple arterial grafting (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (59 Sites)
Showing the first 25 of 59 sites.
- University of Colorado — Boulder, Colorado
- Baystate Health — Springfield, Massachusetts
- Nebraska Heart Hospital — Lincoln, Nebraska
- University of Nebraska Medical Center — Omaha, Nebraska
- NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York
- Icahn School of Medicine, Mount Sinai — New York, New York
- Weil Cornell Medical College Department of Cardiothoracic Surgery — New York, New York
- Lenox Hill Hospital (Northwell) — New York, New York
- NewYork-Presbyterian Queens — New York, New York
- Cleveland Clinic Foundation — Cleveland, Ohio
- Allegheny General Hospital (Cardiovascular Institute) — Pittsburgh, Pennsylvania
- Innsbruck (Medical University) Austria — Innsbruck,
- Krankenhaus Nord Vienna North Hospital — Vienna,
- MU Vienna Austria — Vienna,
- Federal University of Sao Paulo — São Paulo,
- Hamilton General Hospital — Hamilton,
- London Health Sciences Ontario Canada — London,
- University Hospital of Montreal (CHUM) — Montreal,
- University of Ottawa Heart Institute Canada — Ottawa,
- Royal Victoria Hospital (McGill) — Québec,
- Universite Laval Quebec (CRIUCPQ) Canada — Québec,
- Sunnybrook Health Sciences Centre — Toronto,
- Toronto General Hospital — Toronto,
- St. Boniface General Hospital / WHRA — Winnipeg,
- Fuwai Hospital — Beijing,
📞 Contact the Study Coordinator
Phone: (212) 746-1812
Email: mfg9004@med.cornell.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.