Cardiothoracic Surgery

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   ROMA TRIAL

ROMA is a prospective event-driven un-blinded randomized multicenter clinical trial. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG).  All patients will receive a single internal thoracic artery  (ITA) to the left anterior descending coronary artery (LAD). In the MAG group, the major vessel to the lateral wall will be grafted with a radial or a second ITA.  The primary outcome will be a composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all cause mortality. The sample size is estimated at 4300 patients.

Principal Investigator/s: Mario Gaudino, M.D. and Stephem E. Fremes, M.D.
Contact: Renee Aviv, RN 212-746-5194
ClinicalTrials.gov Identifier: NCT03217006
Status: Active
Patient Accrual: Open to Accrual

Hypothesis

  1. The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts (AG) 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. 
  2. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.

Objective

  1. The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more AGs 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.
  2. The secondary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more AGs compared to a single arterial graft is associated with improved survival.

Weill Cornell Medicine Cardiothoracic Surgery
525 East 68th Street
Box 110 Suite M 404
New York, NY 10065

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Mario F. L. Gaudino, M.D.
Phone: (212) 746-1815
Email: mfg9004@med.cornell.edu