AzTrials
AzTrials

Heart DiseasesROMA:WomenNCT04124120

Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

A study testing Single arterial graft and Multiple arterial grafting in people with Heart Diseases and Coronary Artery Disease, run by Weill Medical College of Cornell University at 146 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Single arterial graft and Multiple arterial grafting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,300 participants
Where
146 sitesin 26 countries
Study dates
17 Apr 2023to Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

146 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

Mario Gaudino, Prof/PhD/MD contact

212.746.1812

mfg9004@med.cornell.edu

Stephen Fremes, Prof/MD contact

1 416 480 6073

stephen.fremes@sunnybrook.ca

146 sites in 26 countries

United States42 sites, 41 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48104

    Robert Hawkins, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    John Puskas, MD

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Jessica Rove, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21218

    Jennifer Lawton, MD

    Recruiting

  • NewYork-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

    Sandhya Balaram, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Hasam Balkhy, MD

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Faisal Bakaeen, MD

    Not yet recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Jovan Bozinovski, MD

    Recruiting

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204

    Michael DiMaio, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Brittany Zwischenberger, MD

    Recruiting

  • Englewood Health

    Englewood, New Jersey, 07631

    Molly Schultheis, MD

    Recruiting

  • The University of Texas Medical Health Branch at Galveston

    Galveston, Texas, 77550

    Andre Son, MD

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27858

    Benjamin Degner, MD

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06106

    David Yaffee, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Lauren Barron, MD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Lola Chabtini, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Mohammad Bashir, MD

    Recruiting

  • Nebraska Heart Hospital

    Lincoln, Nebraska, 68526

    Omar Nass

    Not yet recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Joanna Chikwe, MD

    Recruiting

  • Yale University Hospital

    New Haven, Connecticut, 06510

    Roland Assi, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10021

    Mario Gaudino, Prof/PhD/MD, 212-746-1812, mfg9004@med.cornell.edu

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Koji Takeda, MD

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10075

    Nirav Patel, MD

    Not yet recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

    Arash Salemi, MD

    Recruiting

  • Methodist Physicians Health

    Omaha, Nebraska, 68118

    HelenMari Merritt-Genore, DO

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Aleem Siddique, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Marisa Cevasco, MD

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Scott Halbreiner, MD

    Not yet recruiting

  • Pomona Valley Hospital Medical Center

    Pomona, California, 91767

    Christine Montesa, MD

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Neel Sodha, MD

    Recruiting

  • New York Presbyterian Queens

    Queens, New York, 11355

    Charles Mack, MD

    Recruiting

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

    Juan B Grau, MD

    Recruiting

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

    Thomas Schwann, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Matthew Goodwin, MD

    Recruiting

  • UT Health San Antonio

    San Antonio, Texas, 78229

    Dawn Hui, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94118

    Elaine Tseng, MD

    Recruiting

  • Baystate Health

    Springfield, Massachusetts, 01199

    Daniel Engelman, MD

    Recruiting

  • Washington University in St. Louis

    St Louis, Missouri, 63110

    Puja Kachroo, MD

    Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina, 27106

    Bart Imielski, MD

    Recruiting

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

    Completed

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

    Gianluca Torregrossa, MD

    Recruiting

  • Genesis Healthcare System

    Zanesville, Ohio, 43701

    Surender Neravetla, MD

    Recruiting

Other trials in United States

United Kingdom18 sites, 18 recruiting

  • Blackpool Teaching Hospitals NHS Trust

    Blackpool, Lancashire, FY3 8NR

    Grzegorz Laskawski, MD

    Recruiting

  • Royal Papworth NHS Foundation Trust

    Cambridge, CB2 0A

    Ravi De Silva, MD

    Recruiting

  • NHS Golden Jubilee

    Clydebank, G81 4DY

    Nawwar Al-Attar, MD

    Recruiting

  • The Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

    Vipin Zamvar, MD

    Recruiting

  • Hull University Hospitals

    Hull

    Mahmoud Loubani, MD

    Recruiting

  • University Hospitals of Leicester

    Leicester

    Mustafa Zakkar, MD

    Recruiting

  • Liverpool Heart and Chest Hospital Foundation Trust

    Liverpool, L14 3PE

    Bil Kirmani, MD

    Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH

    Cesare Quarto, MD

    Recruiting

  • Imperial College Healthcare NHS Trust

    London, W2 1NY

    Prakash Punjabi, MD

    Recruiting

  • Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

    London

    Gianluca Lucchese, MD

    Recruiting

  • St George's University Hospitals

    London

    Marjan Jahangiri, MD

    Recruiting

  • Manchester University NHS Trust

    Manchester, M13 9WL

    Nnamdi Nwaejike, MD

    Recruiting

  • South Tees Hospitals NHS Trust

    Middlesbrough, TS4 3BW

    Ralph White, MD

    Recruiting

  • Oxford University Hospitals NHS Trust

    Multiple Locations, Oxford

    Antonios Kourliouros, MD

    Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2SB

    Govind Chetty, MBBS

    Recruiting

  • University Hospitals of North Midlands NHS Trust

    Stoke-on-Trent, Staffordshire, ST4 6QG

    Longnathen Balacumaraswami, MD

    Recruiting

  • Mid and South Essex NHS Foundation Trust

    Westcliff-on-Sea

    Arvind Singh

    Recruiting

  • Royal Wolverhampton NHS Trust

    Wolverhampton, WV10 0QP

    Giuseppe Rescigno, MD

    Recruiting

Other trials in United Kingdom

Canada16 sites, 16 recruiting

  • Mazankowski Alberta Heart Institute

    Edmonton, Alberta

    Steven Meyer, MD

    Recruiting

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

    Bindu Bittira, MD

    Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

    Andre Lamy, MD

    Recruiting

  • London Health Sciences

    London, Ontario, N6A 5A5

    David Nagpal, MD

    Recruiting

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

    Philippe Demers, MD

    Recruiting

  • University Hospital of Montreal

    Montreal, Quebec, H2X 3E4

    Jessica Forcillo, MD

    Recruiting

  • Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

    Kevin Lachapelle, MD

    Recruiting

  • Hopital Sacre-Coeur

    Montreal

    Hugues Jeanmart, MD

    Recruiting

  • Fraser Clinical Trials

    New Westminster

    Hossein Shayan, MD

    Recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

    Marc Ruel, MD

    Recruiting

  • Horizon Health Network - Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

    Craig Brown, MD

    Recruiting

  • Newfoundland and Labrador Health Services

    St. John's, Newfoundland and Labrador, A1B 3R4

    Janet Ngu, MD

    Recruiting

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Ste Foy, Quebec, G1V 4G5

    Mohamed Marzouk, MD

    Recruiting

  • Sunnybrook Health Sciences

    Toronto, Ontario, M4N 3M5

    Stephen E Fremes, MD

    Recruiting

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

    Vivek Rao, MD

    Not yet recruiting

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

    Nitin Ghorpade, MD

    Recruiting

Other trials in Canada

Germany16 sites, 15 recruiting

  • Universitäts-Herzzentrum Bad Krozingen Freiburg

    Bad Krozingen, Baden-Wurttemberg, 79189

    Martin Czerny, MD

    Recruiting

  • HDZ NRW Bad Oeynhausen Germany

    Bad Oeynhausen, 32545

    Marcus-Andre Deutsch, MD

    Recruiting

  • Deutsches Herzzentrum der Charite

    Berlin

    Stephan Jacobs, MD

    Recruiting

  • Duisburg Heart Center

    Duisburg, 47137

    Jochen Börgermann, MD

    Not yet recruiting

  • Dusseldorf University

    Düsseldorf, 40225

    Alexander Assmann, MD

    Recruiting

  • University Hospital Erlangen

    Erlangen, 91054

    Completed

  • Essen University

    Essen, 45147

    Matthias K Thielmann, MD

    Recruiting

  • Frankfurt University

    Frankfurt, 60323

    Thomas Holubec, MD

    Not yet recruiting

  • University Hospital of Giessen and Marburg

    Giessen, 35385

    Andreas Boening, MD

    Recruiting

  • University Medical Center of Göttingen

    Göttingen, 37075

    Bernd Danner, MD

    Recruiting

  • Heidelberg University

    Heidelberg

    Rawa Arif, MD

    Recruiting

  • Jena University Hospital

    Jena, 07743

    Torsten Doenst, MD

    Recruiting

  • Heart Center Herzzentrum, Leipzig

    Leipzig, 04289

    Michael Borger, MD

    Recruiting

  • TUM University Hospital German Heart Center

    Munich

    Keti Vitanova, MD

    Recruiting

  • Robert-Bosch-Hospital Stuttgart Germany

    Stuttgart, 70376

    Marc Albert, MD

    Not yet recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

    Terrence J Donovan, MD

    Recruiting

Other trials in Germany

Italy8 sites, 8 recruiting

  • Anthea Hospital

    Bari, 70124

    Giuseppe Speziale, MD

    Recruiting

  • Humanitas Gavazzeni of Bergamo

    Bergamo, 24125

    Alfonso Agnino, MD

    Recruiting

  • Fondazione Poliambulanza

    Brescia, 25124

    Gianni Troise, MD

    Not yet recruiting

  • Maria Cecilia Hospital GVM

    Cotignola, 48033

    Alberto Albertini, MD

    Not yet recruiting

  • Careggi University Hospital

    Florence, 50134

    Massimo Bonacchi, MD

    Recruiting

  • European Hospital

    Roma, 00149

    Ruggero De Paulis, MD

    Recruiting

  • Universita' Cattolica del Sacro Cuore

    Roma, 00168

    Massimo Massetti, MD

    Recruiting

  • Ospedale Le Molinette, Torino

    Torino, 10126

    Mauro Rinaldi, MD

    Not yet recruiting

Other trials in Italy

Austria5 sites, 5 recruiting

  • Medical University of Graz

    Graz, 8010

    Igor Knez, MD

    Recruiting

  • Innsbruck Medical University

    Innsbruck, 6020

    Elfriede Ruttmann-Ulmer, MD

    Recruiting

  • Kepler University Hospital

    Linz

    Andreas F Zierer, MD

    Recruiting

  • Medical University of Vienna

    Vienna, 1090

    Sigrid Sandner, MD

    Recruiting

  • Krankenhaus Nord Vienna North Hospital

    Vienna, 1210

    Berhard Winkler, MD

    Recruiting

Other trials in Austria

China4 sites

  • Fuwai Hospital China

    Beijing, Beijing Municipality, 100037

    Completed

  • Jilin Heart Hospital China

    Changchun, Jilin, 130052

    Completed

  • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Completed

  • Teda Hospital Tianjin China

    Tianjin, Tianjin Municipality, 300456

    Completed

Other trials in China

Spain4 sites, 4 recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Jorge Alcocer, MD

    Recruiting

  • Hospital Universitario del Vinalopo

    Elche, Alicante, 03293

    Jose Albors Martin, MD

    Recruiting

  • Hospital Clinico de San Carlos

    Madrid

    Paula Campelos, MD

    Recruiting

  • NavarraBiomed

    Pamplona

    Javier De Diego Candela, MD

    Recruiting

Other trials in Spain

Brazil3 sites, 3 recruiting

  • Institute of Cardiology Porto Alegre

    Porto Alegre, 9062000

    Renato Kalil, MD

    Not yet recruiting

  • Heart Institute University of São Paulo

    São Paulo, 05508

    Fabio B Jatene, MD

    Recruiting

  • Instituto Dante Pazzanese de Cardiologia

    Vila Mariana, 04012-909

    Renato T Arnoni, MD

    Not yet recruiting

Other trials in Brazil

Netherlands3 sites, 3 recruiting

  • Leiden University Medical Center

    Leiden, South Holland, 2333

    Arend de Weger, MD

    Recruiting

  • Maastricht University Medical Centre

    Maastricht, 6229

    Roberto Lorusso, MD

    Recruiting

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015

    Sabrine Siregar, MD

    Recruiting

Other trials in Netherlands

Poland3 sites, 3 recruiting

  • Medical University Gdansk

    Gdansk, 80-210

    Andrezj Łoś, MD

    Recruiting

  • Medical University of Silesia

    Katowice, 40-055

    Radosław Gocol, MD

    Recruiting

  • Zbigniew Religa Lower Silesian Heart Disease Centre

    Zabrze, 41-800

    Romuald Cichon, MD

    Recruiting

Other trials in Poland

Portugal3 sites, 3 recruiting

  • University Hospital Coimbra

    Coimbra, 3004-561

    Manuel Antunes, MD

    Recruiting

  • Centro Hospitalar Lisboa Ocidental

    Lisbon, 1300-598

    Miguel Sousa Uva, MD

    Not yet recruiting

  • Centro Hospitalar e Universitário Sao Joao

    Porto, 4200-072

    Adelino Leite-Moreira, MD

    Recruiting

Other trials in Portugal

Australia2 sites, 2 recruiting

  • Victorian Heart Hospital

    Clayton, 3168

    Jayme Bennetts, MD

    Recruiting

  • The University of Melbourne

    Melbourne

    Alistair Royse, MD

    Recruiting

Other trials in Australia

Czechia2 sites, 2 recruiting

  • University Hradec Králové

    Hradec Králové, 500 03

    Jan Vojacek, MD

    Recruiting

  • General University Hospital, Prague

    New Town, 128 08

    Tomas Prskavec, MD

    Not yet recruiting

Other trials in Czechia

Denmark2 sites, 2 recruiting

  • Aalborg University Hospital

    Aalborg, 9000

    Gennady V Atroshchenko, MD

    Recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Christian Carranza, MD

    Recruiting

Other trials in Denmark

India2 sites

  • G Kuppuswamy Naidu Memorial Hospital (GKNM)

    Coimbatore, Tamil Nadu, 641037

    Completed

  • Star Hospitals - Hyderabad, India

    Hyderabad, Telangana, 500034

    Completed

Other trials in India

Japan2 sites, 2 recruiting

  • Tokyo Medical and Dental University

    Bunkyō-Ku, Tokyo, 113-8510

    Hirokuni Arai, MD

    Not yet recruiting

  • Saitama Medical University Japan

    Saitama, 350-0451

    Hiroyuki Nakajima, MD

    Not yet recruiting

Other trials in Japan

South Korea2 sites, 2 recruiting

  • Severance Cardiovascular Hospital, Yonsei University College of Medicine

    Seoul, 03722

    Kyung-Jong Yoo, MD

    Not yet recruiting

  • Seoul National University Hospital

    Seoul

    Ho Younh Hwang, MD

    Recruiting

Other trials in South Korea

Sweden2 sites, 2 recruiting

  • Sahlgrenska University Hospital

    Gothenburg

    Anders Jeppsson, MD

    Recruiting

  • Karonlinska University Hospital

    Stockholm, 171 76

    Janice Kallonen, MD

    Recruiting

Other trials in Sweden

Croatia1 site, 1 recruiting

  • University Hospital Dubrava

    Zagreb, 10000

    Igor Rudez, MD

    Recruiting

Other trials in Croatia

Israel1 site

  • Rambam Health Care Campus

    Haifa, 3109601

    Completed

Other trials in Israel

North Macedonia1 site, 1 recruiting

  • Acibadem-Sistina Hospital

    Skopje

    Aleksandar Nikolikj, MD

    Recruiting

Other trials in North Macedonia

Russia1 site

  • National Research Medical Center of the Russian Academy of Sciences - Tomsk, Russia

    Tomsk

    Completed

Other trials in Russia

Serbia1 site, 1 recruiting

  • Dedinje Cardiovascular Institute

    Belgrade, 11000

    Milan Milojevic, MD

    Recruiting

Other trials in Serbia

Singapore1 site, 1 recruiting

  • National University of Singapore

    Singapore, 119077

    Theodoros Kofidis, MD

    Not yet recruiting

Other trials in Singapore

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Zhongzheng, Taipei, 100229

    Yih-Sharng Chen, MD

    Not yet recruiting

Other trials in Taiwan

About this study

Official title: 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:

Read more

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.

Read the 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.

Being tested
Single arterial graft, Multiple arterial grafting
Medical subject headings
Heart Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single arterial graftProcedure or surgery

    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 graftingProcedure or surgery

    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.

Study groups in NCT04124120
Study groupRoleWhat they receive
Single Arterial Graft (SAG) groupExperimentalPatients 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.
Receives: Procedure: Single arterial graft
Multiple Arterial Graft (MAG) groupExperimentalPatients 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.
Receives: Procedure: Multiple arterial grafting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: Postoperatively, minimum 2.5 year follow-up

  2. Primary outcome for aim 2: Disease-specific quality of life

    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.

    Measured: Postoperatively, minimum 2.5 year follow-up

Secondary outcomes (11)

  1. Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.

    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.

    Measured: Postoperatively, minimum 2.5 year follow-up

  2. Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.

    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.

    Measured: Postoperatively, minimum 2.5 year follow-up

  3. Death from any cause

    Another secondary outcome for aim 1: Death will be considered to be cardiac unless a definite non-cardiac cause is identified.

    Measured: Postoperatively, minimum 2.5 year follow-up

  4. Stroke

    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.

    Measured: Postoperatively, minimum 2.5 year follow-up

  5. Non-procedural myocardial infarction

    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.

    Measured: > 48 hours postoperatively, minimum 2.5 year follow-up

  6. Repeat revascularization

    Another secondary outcome for aim 1: Repeat revascularization will include any percutaneous or surgical revascularization on a grafted coronary artery after the initial operation.

    Measured: Postoperatively, minimum 2.5 year follow-up

  7. Readmission for acute coronary syndrome

    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.

    Measured: Postoperatively, minimum 2.5 year follow-up

  8. Readmission for heart failure

    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:

    1. 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.

    Measured: Postoperatively, minimum 2.5 year follow-up

  9. Generic quality of life according to the Short Form Health Survey (SF-12v2)

    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.

    Measured: Postoperatively, minimum 2.5 year follow-up

  10. Generic quality of life according to EuroQuol-5D (EQ-5D)

    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.

    Measured: Postoperatively, minimum 2.5 year follow-up

  11. Mental and physical health symptoms according to PROMIS instruments

    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.

    Measured: Postoperatively, minimum 2.5 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2019
  2. Study start17 Apr 2023
  3. Primary completionMar 2030 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients undergoing coronary artery bypass surgery will be in one of two groups. One group will receive a single arterial graft and the second group will receive two or more arterial grafts.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04124120
Sponsor's protocol ID
1703018094-ROMA-Women
Acronym
ROMA:Women
Status last verified
Mar 2026
First submitted
10 Oct 2019
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Primary outcome data under request

Publications

  • Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. doi: 10.1056/NEJM198601023140101.

    PubMed 3484393

  • Tatoulis J, Buxton BF, Fuller JA. Patencies of 2127 arterial to coronary conduits over 15 years. Ann Thorac Surg. 2004 Jan;77(1):93-101. doi: 10.1016/s0003-4975(03)01331-6.

    PubMed 14726042

  • Lytle BW, Blackstone EH, Loop FD, Houghtaling PL, Arnold JH, Akhrass R, McCarthy PM, Cosgrove DM. Two internal thoracic artery grafts are better than one. J Thorac Cardiovasc Surg. 1999 May;117(5):855-72. doi: 10.1016/S0022-5223(99)70365-X.

    PubMed 10220677

  • Taggart DP, D'Amico R, Altman DG. Effect of arterial revascularisation on survival: a systematic review of studies comparing bilateral and single internal mammary arteries. Lancet. 2001 Sep 15;358(9285):870-5. doi: 10.1016/S0140-6736(01)06069-X.

    PubMed 11567701

  • Yi G, Shine B, Rehman SM, Altman DG, Taggart DP. Effect of bilateral internal mammary artery grafts on long-term survival: a meta-analysis approach. Circulation. 2014 Aug 12;130(7):539-45. doi: 10.1161/CIRCULATIONAHA.113.004255. Epub 2014 Jun 10.

    PubMed 24916209

  • Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available.

    PubMed 22070836

  • Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

    PubMed 25173339

  • Aldea GS, Bakaeen FG, Pal J, Fremes S, Head SJ, Sabik J, Rosengart T, Kappetein AP, Thourani VH, Firestone S, Mitchell JD; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Clinical Practice Guidelines on Arterial Conduits for Coronary Artery Bypass Grafting. Ann Thorac Surg. 2016 Feb;101(2):801-9. doi: 10.1016/j.athoracsur.2015.09.100. Epub 2015 Dec 8.

    PubMed 26680310

  • Benedetto U, Raja SG, Albanese A, Amrani M, Biondi-Zoccai G, Frati G. Searching for the second best graft for coronary artery bypass surgery: a network meta-analysis of randomized controlled trialsdagger. Eur J Cardiothorac Surg. 2015 Jan;47(1):59-65; discussion 65. doi: 10.1093/ejcts/ezu111. Epub 2014 Mar 30.

    PubMed 24686003

Questions about this trial

What is this clinical trial studying?

A study testing Single arterial graft and Multiple arterial grafting in people with Heart Diseases and Coronary Artery Disease, run by Weill Medical College of Cornell University at 146 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, United Kingdom, Canada, Germany, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mario Gaudino, Prof/PhD/MD (212.746.1812, mfg9004@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04124120, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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