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Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Sponsor: Weill Medical College of Cornell University
Summary
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.
Official title: Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2300
Start Date
2023-04-17
Completion Date
2030-03
Last Updated
2026-04-01
Healthy Volunteers
No
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 (146)
Cedars-Sinai Medical Center
Los Angeles, California, United States
Pomona Valley Hospital Medical Center
Pomona, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University Hospital
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
Baystate Health
Springfield, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Nebraska Heart Hospital
Lincoln, Nebraska, United States
Methodist Physicians Health
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Englewood Health
Englewood, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Weill Cornell Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
New York Presbyterian Queens
Queens, New York, United States
Duke University
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Genesis Healthcare System
Zanesville, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
The University of Texas Medical Health Branch at Galveston
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Victorian Heart Hospital
Clayton, Australia
The University of Melbourne
Melbourne, Australia
Medical University of Graz
Graz, Austria
Innsbruck Medical University
Innsbruck, Austria
Kepler University Hospital
Linz, Austria
Medical University of Vienna
Vienna, Austria
Krankenhaus Nord Vienna North Hospital
Vienna, Austria
Institute of Cardiology Porto Alegre
Porto Alegre, Brazil
Heart Institute University of São Paulo
São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
Vila Mariana, Brazil
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Horizon Health Network - Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
University Hospital of Montreal
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Ste Foy, Quebec, Canada
Hopital Sacre-Coeur
Montreal, Canada
Fraser Clinical Trials
New Westminster, Canada
Fuwai Hospital China
Beijing, Beijing Municipality, China
Jilin Heart Hospital China
Changchun, Jilin, China
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Teda Hospital Tianjin China
Tianjin, Tianjin Municipality, China
University Hospital Dubrava
Zagreb, Croatia
University Hradec Králové
Hradec Králové, Czechia
General University Hospital, Prague
New Town, Czechia
Aalborg University Hospital
Aalborg, Denmark
Rigshospitalet
Copenhagen, Denmark
Universitäts-Herzzentrum Bad Krozingen Freiburg
Bad Krozingen, Baden-Wurttemberg, Germany
HDZ NRW Bad Oeynhausen Germany
Bad Oeynhausen, Germany
Deutsches Herzzentrum der Charite
Berlin, Germany
Duisburg Heart Center
Duisburg, Germany
Dusseldorf University
Düsseldorf, Germany
University Hospital Erlangen
Erlangen, Germany
Essen University
Essen, Germany
Frankfurt University
Frankfurt, Germany
University Hospital of Giessen and Marburg
Giessen, Germany
University Medical Center of Göttingen
Göttingen, Germany
Heidelberg University
Heidelberg, Germany
Jena University Hospital
Jena, Germany
Heart Center Herzzentrum, Leipzig
Leipzig, Germany
TUM University Hospital German Heart Center
Munich, Germany
Robert-Bosch-Hospital Stuttgart Germany
Stuttgart, Germany
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
G Kuppuswamy Naidu Memorial Hospital (GKNM)
Coimbatore, Tamil Nadu, India
Star Hospitals - Hyderabad, India
Hyderabad, Telangana, India
Rambam Health Care Campus
Haifa, Israel
Anthea Hospital
Bari, Italy
Humanitas Gavazzeni of Bergamo
Bergamo, Italy
Fondazione Poliambulanza
Brescia, Italy
Maria Cecilia Hospital GVM
Cotignola, Italy
Careggi University Hospital
Florence, Italy
European Hospital
Roma, Italy
Universita' Cattolica del Sacro Cuore
Roma, Italy
Ospedale Le Molinette, Torino
Torino, Italy
Tokyo Medical and Dental University
Bunkyō-Ku, Tokyo, Japan
Saitama Medical University Japan
Saitama, Japan
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Acibadem-Sistina Hospital
Skopje, North Macedonia
Medical University Gdansk
Gdansk, Poland
Medical University of Silesia
Katowice, Poland
Zbigniew Religa Lower Silesian Heart Disease Centre
Zabrze, Poland
University Hospital Coimbra
Coimbra, Portugal
Centro Hospitalar Lisboa Ocidental
Lisbon, Portugal
Centro Hospitalar e Universitário Sao Joao
Porto, Portugal
National Research Medical Center of the Russian Academy of Sciences - Tomsk, Russia
Tomsk, Russia
Dedinje Cardiovascular Institute
Belgrade, Serbia
National University of Singapore
Singapore, Singapore
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Universitario del Vinalopo
Elche, Alicante, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Clinico de San Carlos
Madrid, Spain
NavarraBiomed
Pamplona, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Karonlinska University Hospital
Stockholm, Sweden
National Taiwan University Hospital
Zhongzheng, Taipei, Taiwan
Blackpool Teaching Hospitals NHS Trust
Blackpool, Lancashire, United Kingdom
Oxford University Hospitals NHS Trust
Multiple Locations, Oxford, United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom
Royal Papworth NHS Foundation Trust
Cambridge, United Kingdom
NHS Golden Jubilee
Clydebank, United Kingdom
The Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Hull University Hospitals
Hull, United Kingdom
University Hospitals of Leicester
Leicester, United Kingdom
Liverpool Heart and Chest Hospital Foundation Trust
Liverpool, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
London, United Kingdom
St George's University Hospitals
London, United Kingdom
Manchester University NHS Trust
Manchester, United Kingdom
South Tees Hospitals NHS Trust
Middlesbrough, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Mid and South Essex NHS Foundation Trust
Westcliff-on-Sea, United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom