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

Status: Not yet recruiting
Location: See all (70) 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: No
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
Colorado
University of Colorado
Aurora
Massachusetts
Baystate Health
Springfield
Nebraska
Nebraska Heart Hospital
Lincoln
University of Nebraska Medical Center
Omaha
New York
Icahn School of Medicine, Mount Sinai
New York
Lenox Hill Hospital
New York
Weill Cornell Medicine
New York
Ohio
Cleveland Clinic Foundation
Cleveland
Ohio State University
Columbus
Pennsylvania
Allegheny General Hospital
Pittsburgh
Other Locations
Austria
Medical University of Graz
Graz
Innsbruck Medical University
Innsbruck
Krankenhaus Nord Vienna North Hospital
Vienna
Medical University of Vienna
Vienna
Brazil
Institute of Cardiology Porto Alegre
Porto Alegre
Heart Institute University of São Paulo
São Paulo
Instituto Dante Pazzanese de Cardiologia
Vila Mariana
Canada
Hamilton General Hospital
Hamilton
London Health Sciences
London
Montreal Heart Institute
Montréal
Royal Victoria Hospital
Montréal
University Hospital of Montreal
Montréal
University of Ottawa Heart Institute
Ottawa
Horizon Health Network - Saint John Regional Hospital
Saint John
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Ste Foy
Health Sciences North
Sudbury
Sunnybrook Health Sciences
Toronto
Toronto General Hospital
Toronto
St. Boniface General Hospital
Winnipeg
China
Fuwai Hospital China
Beijing
Jilin Heart Hospital China
Changchun
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Teda Hospital Tianjin China
Tianjin
Croatia
University Hospital Dubrava
Zagreb
Germany
Universitäts-Herzzentrum Bad Krozingen Freiburg
Bad Krozingen
HDZ NRW Bad Oeynhausen Germany
Bad Oeynhausen
Duisburg Heart Center
Duisburg
Essen University
Duisburg
Dusseldorf University
Düsseldorf
University Hospital Erlangen
Erlangen
Frankfurt University
Frankfurt
University Hospital of Giessen and Marburg
Gießen
University Medical Center of Göttingen
Göttingen
Jena University Hospital
Jena
Heart Center Herzzentrum, Leipzig
Leipzig
Robert-Bosch-Hospital Stuttgart Germany
Stuttgart
Krankenhaus der Barmherzigen Brüder Trier
Trier
India
G Kuppuswamy Naidu Memorial Hospital (GKNM)
Coimbatore
Star Hospitals - Hyderabad, India
Hyderabad
Israel
Rambam Health Care Campus
Haifa
Italy
Anthea Hospital
Bari
Fondazione Poliambulanza
Brescia
Maria Cecilia Hospital GVM
Cotignola
European Hospital
Roma
Universita' Cattolica del Sacro Cuore
Roma
Ospedale Le Molinette, Torino
Torino
Japan
Tokyo Medical and Dental University
Bunkyō-ku
Saitama Medical University Japan
Saitama
Netherlands
Maastricht University Medical Centre
Maastricht
Poland
Medical University of Silesia
Katowice
Zbigniew Religa Lower Silesian Heart Disease Centre
Zabrze
Portugal
University Hospital Coimbra
Coimbra
Centro Hospitalar Lisboa Ocidental
Lisboa
Centro Hospitalar e Universitário Sao João
Porto
Republic of Korea
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seúl
Serbia
Dedinje Cardiovascular Institute
Belgrade
Singapore
National University of Singapore
Singapore
Spain
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario del Vinalopo
Elx
Taiwan
National Taiwan University Hospital
Zhongzheng
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: April 2023
Estimated Completion Date: March 2030
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.
Authors
Mario Gaudino, Sean O'Brien, Ingo Kutschka, David Taggart, Ruth Masterson Creber, Stephen Fremes, Karla Ballman, Roberto Lorusso, C. Noel Bairey Merz
Sponsors
Collaborators: Cedars-Sinai Medical Center, Sunnybrook Health Sciences Centre, Columbia University, New York Presbyterian Hospital, Duke University
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov

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