Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts: the ROMA Trial

Status: Recruiting
Location: See all (56) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: No
View:

• 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.

Locations
United States
Colorado
University of Colorado
Recruiting
Boulder
Massachusetts
Baystate Health
Recruiting
Springfield
Nebraska
Nebraska Heart Hospital
Recruiting
Lincoln
University of Nebraska Medical Center
Recruiting
Omaha
New York
Icahn School of Medicine, Mount Sinai
Recruiting
New York
Lenox Hill Hospital (Northwell)
Recruiting
New York
Weil Cornell Medical College Department of Cardiothoracic Surgery
Recruiting
New York
Ohio
Cleveland Clinic Foundation
Recruiting
Cleveland
Pennsylvania
Allegheny General Hospital (Cardiovascular Institute)
Recruiting
Pittsburgh
Other Locations
Austria
Innsbruck (Medical University) Austria
Recruiting
Innsbruck
Krankenhaus Nord Vienna North Hospital
Recruiting
Vienna
MU Vienna Austria
Recruiting
Vienna
Brazil
Federal University of Sao Paulo
Recruiting
São Paulo
Canada
Hamilton General Hospital
Recruiting
Hamilton
London Health Sciences Ontario Canada
Recruiting
London
University Hospital of Montreal (CHUM)
Recruiting
Montréal
University of Ottawa Heart Institute Canada
Recruiting
Ottawa
Royal Victoria Hospital (McGill)
Recruiting
Quebec
Universite Laval Quebec (CRIUCPQ) Canada
Recruiting
Quebec
Sunnybrook Health Sciences Centre
Recruiting
Toronto
Toronto General Hospital
Recruiting
Toronto
St. Boniface General Hospital / WHRA
Recruiting
Winnipeg
China
Fuwai Hospital
Recruiting
Beijing
Jilin Heart Hospital
Recruiting
Changchun
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Recruiting
Shanghai
National Taiwan University Hospital
Recruiting
Taiwan
Teda Hospital (TICH)
Recruiting
Tianjin
Croatia
University Hospital Dubrava
Recruiting
Zagreb
Germany
Duisburg Heart Center
Recruiting
Duisburg
Essen University
Recruiting
Duisburg
Düsseldorf University
Recruiting
Düsseldorf
University Hospital Erlangen
Recruiting
Erlangen
Giessen Hospital
Recruiting
Giessen
University Medical Center of Goettingen
Enrolling by invitation
Göttingen
Jena University Hospital
Recruiting
Jena
Heart Center (Herzzentrum)
Recruiting
Leipzig
HDZ NRW Bad
Recruiting
Oeynhausen
Robert-Bosch-Hospital
Recruiting
Stuttgart
Krankenhaus der Barmherzigen Brüder Trier
Recruiting
Trier
Italy
Anthea Hospital
Recruiting
Bari
Fondazione Poliambulanza
Recruiting
Brescia
Maria Cecilia Hospital GVM
Recruiting
Cotignola
Universita' Cattolica del Sacro Cuore
Recruiting
Roma
European Hospital
Recruiting
Rome
Ospedale Le Molinette
Recruiting
Torino
Japan
Saitama Medical University
Recruiting
Saitama
Netherlands
MUMC Maastricht (University Medical Centre)
Recruiting
Maastricht
Poland
Medical University of Silesia (Katowice)
Recruiting
Katowice
Portugal
Hospitalar de Lisboa Central
Recruiting
Capuchos
University Hospital (Praceta Mota Pinto)
Recruiting
Coimbra
Centro Hospitalar e Universitário São João
Recruiting
Porto
Republic of Korea
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Recruiting
Sinchŏn-dong
Serbia
Dedinje Cardiovascular Institute
Recruiting
Belgrade
Singapore
National University of Singapore
Recruiting
Singapore
Spain
Hospital Univeritario Del Vinalopo
Recruiting
Alicante
Hospital Clinic de Barcelona (ICCV)
Recruiting
Barcelona
Contact Information
Primary
Mario Gaudino, MD
mfg9004@med.cornell.edu
212.746.1812
Backup
Marshagay Rodriques
mar4028@med.cornell.edu
(212) 746-5594
Time Frame
Start Date: January 7, 2018
Estimated Completion Date: January 1, 2030
Participants
Target number of participants: 4300
Treatments
Experimental: Single Arterial Group
Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.
Experimental: Multiple Arterial Group
Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), National Heart, Lung, and Blood Institute (NHLBI)
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov

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