Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial

Status: Recruiting
Location: See all (138) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 grfating (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 grfating (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 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Women patients ≥18 years old.

• Isolated coronary artery bypass grafting.

• Primary (first time) cardiac surgery procedure.

• Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Pomona Valley Hospital Medical Center
RECRUITING
Pomona
University of California, San Francisco
RECRUITING
San Francisco
Colorado
University of Colorado
RECRUITING
Aurora
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale University Hospital
RECRUITING
New Haven
Georgia
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
University of Chicago
RECRUITING
Chicago
Massachusetts
Baystate Health
RECRUITING
Springfield
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Corewell Health William Beaumont University Hospital
RECRUITING
Royal Oak
Missouri
Washington University in St. Louis
RECRUITING
St Louis
North Carolina
Duke University
RECRUITING
Durham
East Carolina University
RECRUITING
Greenville
Wake Forest University
RECRUITING
Winston-salem
Nebraska
Nebraska Heart Hospital
NOT_YET_RECRUITING
Lincoln
Methodist Physicians Health
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Englewood Health
RECRUITING
Englewood
Newark Beth Israel Medical Center
RECRUITING
Newark
The Valley Hospital
RECRUITING
Ridgewood
New York
NewYork-Presbyterian Brooklyn Methodist Hospital
RECRUITING
Brooklyn
Columbia University Medical Center
RECRUITING
New York
Lenox Hill Hospital
NOT_YET_RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
New York Presbyterian Queens
RECRUITING
Queens
Ohio
Cleveland Clinic Foundation
NOT_YET_RECRUITING
Cleveland
Ohio State University
RECRUITING
Columbus
Genesis Healthcare System
RECRUITING
Zanesville
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Allegheny General Hospital
NOT_YET_RECRUITING
Pittsburgh
Lankenau Medical Center
RECRUITING
Wynnewood
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Texas
Baylor Scott & White Research Institute
RECRUITING
Dallas
The University of Texas Medical Health Branch at Galveston
RECRUITING
Galveston
Baylor College of Medicine
RECRUITING
Houston
UT Health San Antonio
RECRUITING
San Antonio
Utah
University of Utah
RECRUITING
Salt Lake City
Other Locations
Australia
Victorian Heart Hospital
RECRUITING
Clayton
The University of Melbourne
RECRUITING
Melbourne
Austria
Medical University of Graz
RECRUITING
Graz
Innsbruck Medical University
RECRUITING
Innsbruck
Kepler University Hospital
RECRUITING
Linz
Krankenhaus Nord Vienna North Hospital
RECRUITING
Vienna
Medical University of Vienna
RECRUITING
Vienna
Brazil
Institute of Cardiology Porto Alegre
NOT_YET_RECRUITING
Porto Alegre
Heart Institute University of São Paulo
RECRUITING
São Paulo
Instituto Dante Pazzanese de Cardiologia
NOT_YET_RECRUITING
Vila Mariana
Canada
Health Sciences North
RECRUITING
Greater Sudbury
Hamilton General Hospital
RECRUITING
Hamilton
London Health Sciences
RECRUITING
London
Hopital Sacre-Coeur
RECRUITING
Montreal
Montreal Heart Institute
RECRUITING
Montreal
Royal Victoria Hospital
RECRUITING
Montreal
University Hospital of Montreal
RECRUITING
Montreal
Fraser Clinical Trials
RECRUITING
New Westminster
University of Ottawa Heart Institute
RECRUITING
Ottawa
Horizon Health Network - Saint John Regional Hospital
RECRUITING
Saint John
NL Health Services
RECRUITING
St. John's
Institut Universitaire de Cardiologie et de Pneumologie de Québec
RECRUITING
Ste Foy
Sunnybrook Health Sciences
RECRUITING
Toronto
Toronto General Hospital
NOT_YET_RECRUITING
Toronto
St. Boniface General Hospital
RECRUITING
Winnipeg
China
Fuwai Hospital China
RECRUITING
Beijing
Jilin Heart Hospital China
RECRUITING
Changchun
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Teda Hospital Tianjin China
NOT_YET_RECRUITING
Tianjin
Croatia
University Hospital Dubrava
RECRUITING
Zagreb
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Rigshospitalet
RECRUITING
Copenhagen
Germany
Universitäts-Herzzentrum Bad Krozingen Freiburg
RECRUITING
Bad Krozingen
HDZ NRW Bad Oeynhausen Germany
RECRUITING
Bad Oeynhausen
Deutsches Herzzentrum der Charite
RECRUITING
Berlin
Duisburg Heart Center
NOT_YET_RECRUITING
Duisburg
Dusseldorf University
RECRUITING
Düsseldorf
University Hospital Erlangen
NOT_YET_RECRUITING
Erlangen
Essen University
NOT_YET_RECRUITING
Essen
Frankfurt University
NOT_YET_RECRUITING
Frankfurt
University Hospital of Giessen and Marburg
RECRUITING
Giessen
University Medical Center of Göttingen
RECRUITING
Göttingen
Jena University Hospital
RECRUITING
Jena
Heart Center Herzzentrum, Leipzig
RECRUITING
Leipzig
Robert-Bosch-Hospital Stuttgart Germany
NOT_YET_RECRUITING
Stuttgart
Krankenhaus der Barmherzigen Brüder Trier
RECRUITING
Trier
India
G Kuppuswamy Naidu Memorial Hospital (GKNM)
RECRUITING
Coimbatore
Star Hospitals - Hyderabad, India
RECRUITING
Hyderabad
Israel
Rambam Health Care Campus
NOT_YET_RECRUITING
Haifa
Italy
Anthea Hospital
RECRUITING
Bari
Humanitas Gavazzeni of Bergamo
RECRUITING
Bergamo
Fondazione Poliambulanza
NOT_YET_RECRUITING
Brescia
Maria Cecilia Hospital GVM
NOT_YET_RECRUITING
Cotignola
Careggi University Hospital
RECRUITING
Florence
European Hospital
RECRUITING
Roma
Universita' Cattolica del Sacro Cuore
RECRUITING
Roma
Ospedale Le Molinette, Torino
NOT_YET_RECRUITING
Torino
Japan
Tokyo Medical and Dental University
NOT_YET_RECRUITING
Bunkyō-ku
Saitama Medical University Japan
NOT_YET_RECRUITING
Saitama
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Maastricht University Medical Centre
RECRUITING
Maastricht
Erasmus Medical Center
RECRUITING
Rotterdam
Poland
Medical University Gdansk
RECRUITING
Gdansk
Medical University of Silesia
RECRUITING
Katowice
Zbigniew Religa Lower Silesian Heart Disease Centre
RECRUITING
Zabrze
Portugal
University Hospital Coimbra
RECRUITING
Coimbra
Centro Hospitalar Lisboa Ocidental
NOT_YET_RECRUITING
Lisbon
Centro Hospitalar e Universitário Sao Joao
RECRUITING
Porto
Centro Hospitalar e Universitário Sao João
NOT_YET_RECRUITING
Porto
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Severance Cardiovascular Hospital, Yonsei University College of Medicine
NOT_YET_RECRUITING
Seoul
Russian Federation
National Research Medical Center of the Russian Academy of Sciences - Tomsk, Russia
RECRUITING
Tomsk
Serbia
Dedinje Cardiovascular Institute
RECRUITING
Belgrade
Singapore
National University of Singapore
NOT_YET_RECRUITING
Singapore
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitario del Vinalopo
RECRUITING
Elche
Hospital Clinico de San Carlos
RECRUITING
Madrid
NavarraBiomed
RECRUITING
Pamplona
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Karonlinska University Hospital
RECRUITING
Stockholm
Taiwan
National Taiwan University Hospital
NOT_YET_RECRUITING
Zhongzheng
United Kingdom
Blackpool Teaching Hospitals NHS Trust
RECRUITING
Blackpool
Royal Papworth NHS Foundation Trust
RECRUITING
Cambridge
NHS Golden Jubilee
RECRUITING
Clydebank
The Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Hull University Hospitals
RECRUITING
Hull
University Hospitals of Leicester
RECRUITING
Leicester
Liverpool Heart and Chest Hospital Foundation Trust
RECRUITING
Liverpool
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
St George's University Hospitals
RECRUITING
London
Manchester University NHS Trust
RECRUITING
Manchester
South Tees Hospitals NHS Trust
RECRUITING
Middlesbrough
Oxford University Hospitals NHS Trust
RECRUITING
Multiple Locations
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
University Hospitals of North Midlands NHS Trust
RECRUITING
Stoke-on-trent
Royal Wolverhampton NHS Trust
RECRUITING
Wolverhampton
Contact Information
Primary
Mario Gaudino, Prof/PhD/MD
mfg9004@med.cornell.edu
212.746.1812
Backup
Stephen Fremes, Prof/MD
stephen.fremes@sunnybrook.ca
1 416 480 6073
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2030-03
Participants
Target number of participants: 2000
Treatments
Experimental: Single Arterial Graft (SAG) 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 Graft (MAG) 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.
Related Therapeutic Areas
Sponsors
Collaborators: Columbia University, New York Presbyterian Hospital, Cedars-Sinai Medical Center, Duke University, Sunnybrook Health Sciences Centre
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov