Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
4300 participants
INTERVENTIONAL
2018-01-07
2030-01-01
Brief Summary
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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.
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Detailed Description
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For more than 20 years it has generally been accepted that patients who receive multiple arterial grafts (AGs) at the time of coronary artery bypass surgery (CABG) have increased postoperative survival compared to those who receive only one AG, especially over the long term (3-5). The current United States and European Guidelines encourage the use of AGs in patients with a long life expectancy (6, 7). Last year, a position paper from the Society of Thoracic Surgeons strongly recommended a wider use of AGs (8).
The putative mechanism underlying the AG hypothesis is greater patency. In line with the original findings of improved LAD graft patency with ITA vs. SVG, data from randomized control trials (RCTs) as well as observational studies and a network meta-analysis (9) have demonstrated that the patency of the RA, as well as the right ITA, exceed that of a SVG, providing mechanistic basis to support the AG hypothesis.
ROMA is a two arm event driven randomized multi-centre trial aimed at evaluating the impact of the use of one ITA vs two or more AGs for CABG on a composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The trial is powered to detect a 20% relative reduction in the primary outcome with 90% power at 5% alpha.
The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of a 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.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Single graft
* Emergency operation
* Evolving myocardial infarction within 48 hours of surgery
* Left ventricular ejection fraction of \< 35%
* Any concomitant cardiac or non-cardiac procedure
* Previous cardiac surgery
* Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduce life expectancy to less than 5 years.
* Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
* Anticipated need for coronary thrombo-endarterectomy
* Planned hybrid revascularization
18 Years
70 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Mario Gaudino, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Stephen Fremes, MD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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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
Countries
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References
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Harskamp RE, Alexander JH, Ferguson TB Jr, Hager R, Mack MJ, Englum B, Wojdyla D, Schulte PJ, Kouchoukos NT, de Winter RJ, Gibson CM, Peterson ED, Harrington RA, Smith PK, Lopes RD. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical Outcomes: Insights From the Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Trial. Circulation. 2016 Jan 12;133(2):131-8. doi: 10.1161/CIRCULATIONAHA.115.015549. Epub 2015 Dec 8.
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Benedetto U, Gaudino M, Caputo M, Tranbaugh RF, Lau C, Di Franco A, Ng C, Girardi LN, Angelini GD. Right internal thoracic artery versus radial artery as the second best arterial conduit: Insights from a meta-analysis of propensity-matched data on long-term survival. J Thorac Cardiovasc Surg. 2016 Oct;152(4):1083-1091.e15. doi: 10.1016/j.jtcvs.2016.05.022. Epub 2016 May 28.
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Other Identifiers
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1703018094
Identifier Type: -
Identifier Source: org_study_id
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