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Randomization of Single vs Multiple Arterial Grafts
Sponsor: Weill Medical College of Cornell University
Summary
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.
Official title: Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
4300
Start Date
2018-01-07
Completion Date
2030-01-01
Last Updated
2025-05-23
Healthy Volunteers
No
Conditions
Interventions
Single arterial graft
This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
Multiple arterial grafting
This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.
Locations (59)
University of Colorado
Boulder, Colorado, United States
Baystate Health
Springfield, Massachusetts, United States
Nebraska Heart Hospital
Lincoln, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Icahn School of Medicine, Mount Sinai
New York, New York, United States
Weil Cornell Medical College Department of Cardiothoracic Surgery
New York, New York, United States
Lenox Hill Hospital (Northwell)
New York, New York, United States
NewYork-Presbyterian Queens
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Allegheny General Hospital (Cardiovascular Institute)
Pittsburgh, Pennsylvania, United States
Innsbruck (Medical University) Austria
Innsbruck, Austria
Krankenhaus Nord Vienna North Hospital
Vienna, Austria
MU Vienna Austria
Vienna, Austria
Federal University of Sao Paulo
São Paulo, Brazil
Hamilton General Hospital
Hamilton, Canada
London Health Sciences Ontario Canada
London, Canada
University Hospital of Montreal (CHUM)
Montreal, Canada
University of Ottawa Heart Institute Canada
Ottawa, Canada
Royal Victoria Hospital (McGill)
Québec, Canada
Universite Laval Quebec (CRIUCPQ) Canada
Québec, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
Toronto General Hospital
Toronto, Canada
St. Boniface General Hospital / WHRA
Winnipeg, Canada
Fuwai Hospital
Beijing, China
Jilin Heart Hospital
Changchun, China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
National Taiwan University Hospital
Taiwan, China
Teda Hospital (TICH)
Tianjin, China
University Hospital Dubrava
Zagreb, Croatia
General University Hospital, Prague
Prague, Czechia
Duisburg Heart Center
Duisburg, Germany
Essen University
Duisburg, Germany
Düsseldorf University
Düsseldorf, Germany
University Hospital Erlangen
Erlangen, Germany
Giessen Hospital
Giessen, Germany
University Medical Center of Goettingen
Göttingen, Germany
Jena University Hospital
Jena, Germany
Heart Center (Herzzentrum)
Leipzig, Germany
HDZ NRW Bad
Oeynhausen, Germany
Robert-Bosch-Hospital
Stuttgart, Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Anthea Hospital
Bari, Italy
Fondazione Poliambulanza
Brescia, Italy
Maria Cecilia Hospital GVM
Cotignola, Italy
Universita' Cattolica del Sacro Cuore
Roma, Italy
European Hospital
Rome, Italy
Ospedale Le Molinette
Torino, Italy
Saitama Medical University
Saitama, Japan
MUMC Maastricht (University Medical Centre)
Maastricht, Netherlands
Medical University of Silesia (Katowice)
Katowice, Poland
Hospitalar de Lisboa Central
Capuchos, Portugal
University Hospital (Praceta Mota Pinto)
Coimbra, Portugal
Centro Hospitalar e Universitário São João
Porto, Portugal
Dedinje Cardiovascular Institute
Belgrade, Serbia
National University of Singapore
Singapore, Singapore
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Sinchŏn-dong, South Korea
Hospital Univeritario Del Vinalopo
Alicante, Spain
Hospital Clinic de Barcelona (ICCV)
Barcelona, Spain