Condition: Coronary Artery Disease · Heart Diseases · Sponsor: Weill Medical College of Cornell University
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.
This description comes directly from the study's public registry record.
Mario Gaudino, MD · 212.746.1812 · mfg9004@med.cornell.edu
Marshagay Rodriques · (212) 746-5594 · mar4028@med.cornell.edu
Always discuss trial participation with your own doctor first.
| University of Colorado | Boulder, Colorado, United States | Recruiting |
| Baystate Health | Springfield, Massachusetts, United States | Recruiting |
| Nebraska Heart Hospital | Lincoln, Nebraska, United States | Recruiting |
| University of Nebraska Medical Center | Omaha, Nebraska, United States | Recruiting |
| NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn, New York, United States | Recruiting |
| Icahn School of Medicine, Mount Sinai | New York, New York, United States | Recruiting |
| Weil Cornell Medical College Department of Cardiothoracic Surgery | New York, New York, United States | Recruiting |
| Lenox Hill Hospital (Northwell) | New York, New York, United States | Recruiting |
| NewYork-Presbyterian Queens | New York, New York, United States | Recruiting |
| Cleveland Clinic Foundation | Cleveland, Ohio, United States | Recruiting |
| Allegheny General Hospital (Cardiovascular Institute) | Pittsburgh, Pennsylvania, United States | Recruiting |
| Innsbruck (Medical University) Austria | Innsbruck, Austria | Recruiting |
+ 47 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03217006