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

March 31, 2026 updated by: Weill Medical College of Cornell University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

ROMA:Women will leverage the infrastructure and the existing women population of the ROMA trial. ROMA:Women has two key Aims. In Aim 1, 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. In Aim 2, 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. Differences by important 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.

ROMA:Women is a two-arm, international, multi-center, randomized clinical trial nested in the ROMA trial. ROMA:Women will include all the women enrolled in the parent ROMA trial and will leverage the existing ROMA infrastructure including clinical trial unit, database, case report forms (CRF), randomization system, site training resources, informed consent forms (ICF), regulatory approvals, Central Events Review Committee (CEC) processes/personnel, network of participating sites, site PIs, and study coordinators. The planned randomization procedure, interventions and treatment arms, outcome assessments and follow-up protocol of ROMA:Women are identical to those of the currently ongoing parent ROMA trial. The sites participating in ROMA will continue enrollment of women after the completion of the ROMA trial and additional sites will also be opened to reach the target sample size of ROMA:Women.

Study Type

Interventional

Enrollment (Estimated)

2300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Clayton, Australia, 3168
        • Recruiting
        • Victorian Heart Hospital
        • Contact:
          • Jayme Bennetts, MD
      • Melbourne, Australia
        • Recruiting
        • The University of Melbourne
        • Contact:
          • Alistair Royse, MD
  • Austria
      • Graz, Austria, 8010
        • Recruiting
        • Medical University of Graz
        • Contact:
          • Igor Knez, MD
      • Innsbruck, Austria, 6020
        • Recruiting
        • Innsbruck Medical University
        • Contact:
          • Elfriede Ruttmann-Ulmer, MD
      • Linz, Austria
        • Recruiting
        • Kepler University Hospital
        • Contact:
          • Andreas F Zierer, MD
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
          • Sigrid Sandner, MD
      • Vienna, Austria, 1210
        • Recruiting
        • Krankenhaus Nord Vienna North Hospital
        • Contact:
          • Berhard Winkler, MD
  • Brazil
      • Porto Alegre, Brazil, 9062000
        • Not yet recruiting
        • Institute of Cardiology Porto Alegre
        • Contact:
          • Renato Kalil, MD
      • São Paulo, Brazil, 05508
        • Recruiting
        • Heart Institute University of São Paulo
        • Contact:
          • Fabio B Jatene, MD
      • Vila Mariana, Brazil, 04012-909
        • Not yet recruiting
        • Instituto Dante Pazzanese de Cardiologia
        • Contact:
          • Renato T Arnoni, MD
  • Canada
      • Montreal, Canada
        • Recruiting
        • Hopital Sacre-Coeur
        • Contact:
          • Hugues Jeanmart, MD
      • New Westminster, Canada
        • Recruiting
        • Fraser Clinical Trials
        • Contact:
          • Hossein Shayan, MD
    • Alberta
      • Edmonton, Alberta, Canada
        • Recruiting
        • Mazankowski Alberta Heart Institute
        • Contact:
          • Steven Meyer, MD
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Recruiting
        • St. Boniface General Hospital
        • Contact:
          • Nitin Ghorpade, MD
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Recruiting
        • Horizon Health Network - Saint John Regional Hospital
        • Contact:
          • Craig Brown, MD
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3R4
        • Recruiting
        • Newfoundland and Labrador Health Services
        • Contact:
          • Janet Ngu, MD
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • Health Sciences North
        • Contact:
          • Bindu Bittira, MD
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton General Hospital
        • Contact:
          • Andre Lamy, MD
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences
        • Contact:
          • David Nagpal, MD
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:
          • Marc Ruel, MD
      • Toronto, Ontario, Canada, M5G 2C4
        • Not yet recruiting
        • Toronto General Hospital
        • Contact:
          • Vivek Rao, MD
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences
        • Contact:
          • Stephen E Fremes, MD
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Montreal Heart Institute
        • Contact:
          • Philippe Demers, MD
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • University Hospital of Montreal
        • Contact:
          • Jessica Forcillo, MD
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Royal Victoria Hospital
        • Contact:
          • Kevin Lachapelle, MD
      • Ste Foy, Quebec, Canada, G1V 4G5
        • Recruiting
        • Institut Universitaire de cardiologie et de pneumologie de Quebec
        • Contact:
          • Mohamed Marzouk, MD
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100037
        • Completed
        • Fuwai Hospital China
    • Jilin
      • Changchun, Jilin, China, 130052
        • Completed
        • Jilin Heart Hospital China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Completed
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300456
        • Completed
        • Teda Hospital Tianjin China
  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • University Hospital Dubrava
        • Contact:
          • Igor Rudez, MD
  • Czechia
      • Hradec Králové, Czechia, 500 03
        • Recruiting
        • University Hradec Králové
        • Contact:
          • Jan Vojacek, MD
      • New Town, Czechia, 128 08
        • Not yet recruiting
        • General University Hospital, Prague
        • Contact:
          • Tomas Prskavec, MD
  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Aalborg University Hospital
        • Contact:
          • Gennady V Atroshchenko, MD
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
          • Christian Carranza, MD
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • HDZ NRW Bad Oeynhausen Germany
        • Contact:
          • Marcus-Andre Deutsch, MD
      • Berlin, Germany
        • Recruiting
        • Deutsches Herzzentrum der Charité
        • Contact:
          • Stephan Jacobs, MD
      • Duisburg, Germany, 47137
        • Not yet recruiting
        • Duisburg Heart Center
        • Contact:
          • Jochen Börgermann, MD
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Düsseldorf University
        • Contact:
          • Alexander Assmann, MD
      • Erlangen, Germany, 91054
        • Completed
        • University Hospital Erlangen
      • Essen, Germany, 45147
        • Recruiting
        • Essen University
        • Contact:
          • Matthias K Thielmann, MD
      • Frankfurt, Germany, 60323
        • Not yet recruiting
        • Frankfurt University
        • Contact:
          • Thomas Holubec, MD
      • Giessen, Germany, 35385
        • Recruiting
        • University Hospital of Giessen and Marburg
        • Contact:
          • Andreas Boening, MD
      • Göttingen, Germany, 37075
        • Recruiting
        • University Medical Center of Göttingen
        • Contact:
          • Bernd Danner, MD
      • Heidelberg, Germany
        • Recruiting
        • Heidelberg University
        • Contact:
          • Rawa Arif, MD
      • Jena, Germany, 07743
        • Recruiting
        • Jena University Hospital
        • Contact:
          • Torsten Doenst, MD
      • Leipzig, Germany, 04289
        • Recruiting
        • Heart Center Herzzentrum, Leipzig
        • Contact:
          • Michael Borger, MD
      • Munich, Germany
        • Recruiting
        • TUM University Hospital German Heart Center
        • Contact:
          • Keti Vitanova, MD
      • Stuttgart, Germany, 70376
        • Not yet recruiting
        • Robert-Bosch-Hospital Stuttgart Germany
        • Contact:
          • Marc Albert, MD
      • Trier, Germany, 54292
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier
        • Contact:
          • Terrence J Donovan, MD
    • Baden-Wurttemberg
      • Bad Krozingen, Baden-Wurttemberg, Germany, 79189
        • Recruiting
        • Universitäts-Herzzentrum Bad Krozingen Freiburg
        • Contact:
          • Martin Czerny, MD
  • India
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641037
        • Completed
        • G Kuppuswamy Naidu Memorial Hospital (GKNM)
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Completed
        • Star Hospitals - Hyderabad, India
  • Israel
      • Haifa, Israel, 3109601
        • Completed
        • Rambam Health Care Campus
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • Anthea Hospital
        • Contact:
          • Giuseppe Speziale, MD
      • Bergamo, Italy, 24125
        • Recruiting
        • Humanitas Gavazzeni of Bergamo
        • Contact:
          • Alfonso Agnino, MD
      • Brescia, Italy, 25124
        • Not yet recruiting
        • Fondazione Poliambulanza
        • Contact:
          • Gianni Troise, MD
      • Cotignola, Italy, 48033
        • Not yet recruiting
        • Maria Cecilia Hospital GVM
        • Contact:
          • Alberto Albertini, MD
      • Florence, Italy, 50134
        • Recruiting
        • Careggi University Hospital
        • Contact:
          • Massimo Bonacchi, MD
      • Roma, Italy, 00149
        • Recruiting
        • European Hospital
        • Contact:
          • Ruggero De Paulis, MD
      • Roma, Italy, 00168
        • Recruiting
        • Universita' Cattolica del Sacro Cuore
        • Contact:
          • Massimo Massetti, MD
      • Torino, Italy, 10126
        • Not yet recruiting
        • Ospedale Le Molinette, Torino
        • Contact:
          • Mauro Rinaldi, MD
  • Japan
      • Saitama, Japan, 350-0451
        • Not yet recruiting
        • Saitama Medical University Japan
        • Contact:
          • Hiroyuki Nakajima, MD
    • Tokyo
      • Bunkyō-Ku, Tokyo, Japan, 113-8510
        • Not yet recruiting
        • Tokyo Medical and Dental University
        • Contact:
          • Hirokuni Arai, MD
  • Netherlands
      • Maastricht, Netherlands, 6229
        • Recruiting
        • Maastricht University Medical Centre
        • Contact:
          • Roberto Lorusso, MD
    • South Holland
      • Leiden, South Holland, Netherlands, 2333
        • Recruiting
        • Leiden University Medical Center
        • Contact:
          • Arend de Weger, MD
      • Rotterdam, South Holland, Netherlands, 3015
        • Recruiting
        • Erasmus Medical Center
        • Contact:
          • Sabrine Siregar, MD
  • North Macedonia
      • Skopje, North Macedonia
        • Recruiting
        • Acibadem-Sistina Hospital
        • Contact:
          • Aleksandar Nikolikj, MD
  • Poland
      • Gdansk, Poland, 80-210
        • Recruiting
        • Medical University Gdansk
        • Contact:
          • Andrezj Łoś, MD
      • Katowice, Poland, 40-055
        • Recruiting
        • Medical University of Silesia
        • Contact:
          • Radosław Gocol, MD
      • Zabrze, Poland, 41-800
        • Recruiting
        • Zbigniew Religa Lower Silesian Heart Disease Centre
        • Contact:
          • Romuald Cichon, MD
  • Portugal
      • Coimbra, Portugal, 3004-561
        • Recruiting
        • University Hospital Coimbra
        • Contact:
          • Manuel Antunes, MD
      • Lisbon, Portugal, 1300-598
        • Not yet recruiting
        • Centro Hospitalar Lisboa Ocidental
        • Contact:
          • Miguel Sousa Uva, MD
      • Porto, Portugal, 4200-072
        • Recruiting
        • Centro Hospitalar e Universitário Sao João
        • Contact:
          • Adelino Leite-Moreira, MD
  • Russia
      • Tomsk, Russia
        • Completed
        • National Research Medical Center of the Russian Academy of Sciences - Tomsk, Russia
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Dedinje Cardiovascular Institute
        • Contact:
          • Milan Milojevic, MD
  • Singapore
      • Singapore, Singapore, 119077
        • Not yet recruiting
        • National University of Singapore
        • Contact:
          • Theodoros Kofidis, MD
  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Ho Younh Hwang, MD
      • Seoul, South Korea, 03722
        • Not yet recruiting
        • Severance Cardiovascular Hospital, Yonsei University College of Medicine
        • Contact:
          • Kyung-Jong Yoo, MD
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Jorge Alcocer, MD
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico de San Carlos
        • Contact:
          • Paula Campelos, MD
      • Pamplona, Spain
        • Recruiting
        • Navarrabiomed
        • Contact:
          • Javier De Diego Candela, MD
    • Alicante
      • Elche, Alicante, Spain, 03293
        • Recruiting
        • Hospital Universitario del Vinalopó
        • Contact:
          • Jose Albors Martin, MD
  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
          • Anders Jeppsson, MD
      • Stockholm, Sweden, 171 76
        • Recruiting
        • Karonlinska University Hospital
        • Contact:
          • Janice Kallonen, MD
  • Taiwan
    • Taipei
      • Zhongzheng, Taipei, Taiwan, 100229
        • Not yet recruiting
        • National Taiwan University Hospital
        • Contact:
          • Yih-Sharng Chen, MD
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0A
        • Recruiting
        • Royal Papworth NHS Foundation Trust
        • Contact:
          • Ravi De Silva, MD
      • Clydebank, United Kingdom, G81 4DY
        • Recruiting
        • NHS Golden Jubilee
        • Contact:
          • Nawwar Al-Attar, MD
      • Edinburgh, United Kingdom, EH16 4SA
        • Recruiting
        • The Royal Infirmary of Edinburgh
        • Contact:
          • Vipin Zamvar, MD
      • Hull, United Kingdom
        • Recruiting
        • Hull University Hospitals
        • Contact:
          • Mahmoud Loubani, MD
      • Leicester, United Kingdom
        • Recruiting
        • University Hospitals of Leicester
        • Contact:
          • Mustafa Zakkar, MD
      • Liverpool, United Kingdom, L14 3PE
        • Recruiting
        • Liverpool Heart and Chest Hospital Foundation Trust
        • Contact:
          • Bil Kirmani, MD
      • London, United Kingdom, W2 1NY
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
          • Prakash Punjabi, MD
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Cesare Quarto, MD
      • London, United Kingdom
        • Recruiting
        • St George's University Hospitals
        • Contact:
          • Marjan Jahangiri, MD
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
        • Contact:
          • Gianluca Lucchese, MD
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester University NHS Trust
        • Contact:
          • Nnamdi Nwaejike, MD
      • Middlesbrough, United Kingdom, TS4 3BW
        • Recruiting
        • South Tees Hospitals NHS Trust
        • Contact:
          • Ralph White, MD
      • Sheffield, United Kingdom, S10 2SB
        • Recruiting
        • Sheffield Teaching Hospitals NHS Foundation Trust
        • Contact:
          • Govind Chetty, MBBS
      • Westcliff-on-Sea, United Kingdom
        • Recruiting
        • Mid and South Essex NHS Foundation Trust
        • Contact:
          • Arvind Singh
      • Wolverhampton, United Kingdom, WV10 0QP
        • Recruiting
        • Royal Wolverhampton Nhs Trust
        • Contact:
          • Giuseppe Rescigno, MD
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Recruiting
        • Blackpool Teaching Hospitals NHS Trust
        • Contact:
          • Grzegorz Laskawski, MD
    • Oxford
      • Multiple Locations, Oxford, United Kingdom
        • Recruiting
        • Oxford University Hospitals NHS Trust
        • Contact:
          • Antonios Kourliouros, MD
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • Recruiting
        • University Hospitals of North Midlands NHS Trust
        • Contact:
          • Longnathen Balacumaraswami, MD
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
          • Joanna Chikwe, MD
      • Pomona, California, United States, 91767
        • Recruiting
        • Pomona Valley Hospital Medical Center
        • Contact:
          • Christine Montesa, MD
      • San Francisco, California, United States, 94118
        • Recruiting
        • University of California, San Francisco
        • Contact:
          • Elaine Tseng, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Jessica Rove, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Hartford Hospital
        • Contact:
          • David Yaffee, MD
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University Hospital
        • Contact:
          • Roland Assi, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
          • John Puskas, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
          • Hasam Balkhy, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
          • Lola Chabtini, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Mohammad Bashir, MD
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Johns Hopkins University
        • Contact:
          • Jennifer Lawton, MD
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Recruiting
        • Baystate Health
        • Contact:
          • Daniel Engelman, MD
      • Worcester, Massachusetts, United States, 01655
        • Completed
        • University of Massachusetts Chan Medical School
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Recruiting
        • University of Michigan
        • Contact:
          • Robert Hawkins, MD
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Corewell Health William Beaumont University Hospital
        • Contact:
          • Thomas Schwann, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis
        • Contact:
          • Puja Kachroo, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Not yet recruiting
        • Nebraska Heart Hospital
        • Contact:
          • Omar Nass
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
          • Aleem Siddique, MD
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Methodist Physicians Health
        • Contact:
          • HelenMari Merritt-Genore, DO
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Englewood Health
        • Contact:
          • Molly Schultheis, MD
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Contact:
          • Arash Salemi, MD
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • The Valley Hospital
        • Contact:
          • Juan B Grau, MD
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • NewYork-Presbyterian Brooklyn Methodist Hospital
        • Contact:
          • Sandhya Balaram, MD
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
          • Koji Takeda, MD
      • New York, New York, United States, 10075
        • Not yet recruiting
        • Lenox Hill Hospital
        • Contact:
          • Nirav Patel, MD
      • Queens, New York, United States, 11355
        • Recruiting
        • New York Presbyterian Queens
        • Contact:
          • Charles Mack, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
          • Brittany Zwischenberger, MD
      • Greenville, North Carolina, United States, 27858
        • Recruiting
        • East Carolina University
        • Contact:
          • Benjamin Degner, MD
      • Winston-Salem, North Carolina, United States, 27106
        • Recruiting
        • Wake Forest University
        • Contact:
          • Bart Imielski, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic Foundation
        • Contact:
          • Faisal Bakaeen, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Contact:
          • Jovan Bozinovski, MD
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis HealthCare System
        • Contact:
          • Surender Neravetla, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
          • Marisa Cevasco, MD
      • Pittsburgh, Pennsylvania, United States, 15212
        • Not yet recruiting
        • Allegheny General Hospital
        • Contact:
          • Scott Halbreiner, MD
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Contact:
          • Gianluca Torregrossa, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
          • Neel Sodha, MD
    • Texas
      • Dallas, Texas, United States, 75204
        • Recruiting
        • Baylor Scott & White Research Institute
        • Contact:
          • Michael DiMaio, MD
      • Galveston, Texas, United States, 77550
        • Recruiting
        • The University of Texas Medical Health Branch at Galveston
        • Contact:
          • Andre Son, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
          • Lauren Barron, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health San Antonio
        • Contact:
          • Dawn Hui, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Contact:
          • Matthew Goodwin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women patients ≥18 years old.
  2. Isolated coronary artery bypass grafting.
  3. Primary (first time) cardiac surgery procedure.
  4. 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.

Exclusion Criteria:

  • Male gender
  • Single graft
  • Emergency operation
  • Myocardial infarction within 72 hours of surgery
  • Left ventricular ejection fraction < 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 reduces 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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.
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
Time Frame: Postoperatively, minimum 2.5 year follow-up
The primary outcome for aim 1 will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (>48 hours after surgery), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
Postoperatively, minimum 2.5 year follow-up
Primary outcome for aim 2: Disease-specific quality of life
Time Frame: Postoperatively, minimum 2.5 year follow-up

Assessed using the Seattle Angina Questionnaire (SAQ), a validated 19-item questionnaire that measures five domains related to coronary disease: angina frequency, physical limitations, quality of life, angina stability, and treatment satisfaction. Scores range from 0 to 100 with higher scores indicating fewer symptoms and better health status. The minimum clinically important difference on the SAQ is 5 points.

The primary endpoint for aim 2 is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline.
Postoperatively, minimum 2.5 year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.
Time Frame: Postoperatively, minimum 2.5 year follow-up

One of the secondary outcomes for aim 1: It will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (>48 hours after surgery), and repeat revascularization.

This is the primary outcome of the parent ROMA trial.
Postoperatively, minimum 2.5 year follow-up
Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
Time Frame: Postoperatively, minimum 2.5 year follow-up
Another secondary outcome for aim 1: It will be a composite of the first occurrence of death from cardiac cause, any stroke, non-procedural myocardial infarction (>48 hours after surgery), repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure.
Postoperatively, minimum 2.5 year follow-up
Death from any cause
Time Frame: Postoperatively, minimum 2.5 year follow-up
Another secondary outcome for aim 1: Death will be considered to be cardiac unless a definite non-cardiac cause is identified.
Postoperatively, minimum 2.5 year follow-up
Stroke
Time Frame: Postoperatively, minimum 2.5 year follow-up

Another secondary outcome for aim 1: Based on the American Heart Association/American Stroke Association Expert Consensus stroke definition, stroke will be identified in case of:

  1. pathological, imaging, or other objective evidence of cerebral ischemic injury in a defined vascular distribution; OR
  2. clinical evidence of cerebral ischemic injury based on symptoms persisting ≥24 hours or until death, and other etiologies excluded.
Postoperatively, minimum 2.5 year follow-up
Non-procedural myocardial infarction
Time Frame: > 48 hours postoperatively, minimum 2.5 year follow-up

Another secondary outcome for aim 1: Based on the 4th Universal Definition, non-periprocedural myocardial infarction will be identified in case of detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia with at least one of the following:

  1. symptoms of ischemia
  2. electrocardiogram changes indicative of new ischemia (new ST-T changes or new left bundle branch block)
  3. development of pathological Q waves in the electrocardiogram
  4. imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
> 48 hours postoperatively, minimum 2.5 year follow-up
Repeat revascularization
Time Frame: Postoperatively, minimum 2.5 year follow-up
Another secondary outcome for aim 1: Repeat revascularization will include any percutaneous or surgical revascularization on a grafted coronary artery after the initial operation.
Postoperatively, minimum 2.5 year follow-up
Readmission for acute coronary syndrome
Time Frame: Postoperatively, minimum 2.5 year follow-up
Another secondary outcome for aim 1: Prolonged ischemic symptoms at rest (usually ≥10 minutes in duration), or accelerating pattern of chest pain that occurs with a lower activity threshold (CCS class III or IV) considered to be myocardial ischemia upon final diagnosis resulting in an unscheduled visit to a healthcare facility resulting in an overnight stay generally within 24 hours of the most recent symptoms, cardiac biomarkers not meeting MI criteria, and ECG or angiographic evidence of ischemia.
Postoperatively, minimum 2.5 year follow-up
Readmission for heart failure
Time Frame: Postoperatively, minimum 2.5 year follow-up

Another secondary outcome for aim 1: While patients may have multiple simultaneous disease processes, for the outcome event of heart failure requiring hospitalization, the diagnosis of congestive heart failure would need to be the primary process. Heart failure (HF) requiring hospitalization is defined as an event that meets the following criteria:

i. Requires hospitalization AND ii. Clinical symptoms of heart failure AND iii. Physical signs of heart failure AND iv. Need for additional/increased therapy AND v. No other non-cardiac etiology (such as chronic obstructive pulmonary disease, hepatic cirrhosis, acute renal failure, or venous insufficiency) and no other cardiac etiology (such as pulmonary embolus, cor pulmonale, primary pulmonary hypertension, or congenital heart disease) for signs or symptoms are identified.
Postoperatively, minimum 2.5 year follow-up
Generic quality of life according to the Short Form Health Survey (SF-12v2)
Time Frame: Postoperatively, minimum 2.5 year follow-up

Secondary outcomes for aim 2: The SF-12v12 measures eight dimensions of health: physical functioning, role limitations due to physical problems, bodily pain, vitality, general health perception, social function, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100 with higher scores indicating better health status.

The SF-12v2 has two summary measures: physical and mental self-perceived health with norm-based methods that standardize the score to a mean of 50 and standard deviation of 10.
Postoperatively, minimum 2.5 year follow-up
Generic quality of life according to EuroQuol-5D (EQ-5D)
Time Frame: Postoperatively, minimum 2.5 year follow-up
Secondary outcomes for aim 2: EQ-5D is a five-item instrument to assess health status in the following five dimensions: mobility, self-care, usual activity, pain or discomfort, and anxiety or depression. Individual domain scores will be converted to a summary index representing utility weights, which allow conduct of cost-effectiveness analyses.
Postoperatively, minimum 2.5 year follow-up
Mental and physical health symptoms according to PROMIS instruments
Time Frame: Postoperatively, minimum 2.5 year follow-up
Secondary outcomes for aim 2: Physical and mental health symptoms and physical functioning will be measured with standardized PROMIS instruments, including: Pain interference, Neuropathic Pain, Fatigue, Sleep disturbance, Depression, Anxiety, and Physical Function. A mean of 50 and a standard deviation of 10 represent the general population in the US.
Postoperatively, minimum 2.5 year follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other recorded outcomes (safety endpoints)
Time Frame: Within 30 days of surgery or during index hospitalization, whichever is longer.
30-day mortality and major postoperative complications (revision for bleeding, perioperative MI (<48 hours after surgery), need for dialysis, need for tracheostomy, and surgical site complications).
Within 30 days of surgery or during index hospitalization, whichever is longer.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Sunnybrook Health Sciences Centre
Columbia University
Duke University
Cedars-Sinai Medical Center
New York Presbyterian Hospital

Investigators

  • Principal Investigator: Mario Gaudino, Prof/PhD/MD, Weill Medical College of Cornell University
  • Principal Investigator: Ruth Masterson Creber, RN, PhD, Columbia University
  • Principal Investigator: C. Noel Bairey Merz, MD, Cedars-Sinai
  • Principal Investigator: Karla Ballman, PhD, Weill Medical College of Cornell University
  • Principal Investigator: Sean O'Brien, PhD, Duke University
  • Principal Investigator: Stephen Fremes, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1703018094-ROMA-Women

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Primary outcome data under request

IPD Sharing Time Frame

From publication until the third year after publication

IPD Sharing Access Criteria

Research scope

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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