Recruiting

Single vs. Multiple

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04124120

Conditions

Heart Diseases

Coronary Artery Disease

Coronary Artery Bypass Grafting

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single arterial graft

Multiple arterial grafting

Study Details

Brief summary:

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG).

The specific aims of ROMA:Women are:

Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time.

Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events.

Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups.

Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated.

Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG.

Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG.

Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

Conditions

Heart Diseases

Coronary Artery Disease

Coronary Artery Bypass Grafting

Study ID

NCT04124120

Start date

Apr 17, 2023

Status verified date

Mar, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Single arterial graft

This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.

Multiple arterial grafting

This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.

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 ]
  • Primary outcome for aim 2: Disease-specific quality of life [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]

Central Contacts and Locations

Central contacts

Mario Gaudino, Prof/PhD/MD

212.746.1812mfg9004@med.cornell.edu

Stephen Fremes, Prof/MD

1 416 480 6073stephen.fremes@sunnybrook.ca

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Pomona Valley Hospital Medical Center

Recruiting

Pomona, California, United States, 91767

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94118

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Yale University Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Baystate Health

Recruiting

Springfield, Massachusetts, United States, 01199

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48104

Corewell Health William Beaumont University Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Methodist Physicians Health

Recruiting

Omaha, Nebraska, United States, 68118

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Englewood Health

Recruiting

Englewood, New Jersey, United States, 07631

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

The Valley Hospital

Recruiting

Ridgewood, New Jersey, United States, 07450

NewYork-Presbyterian Brooklyn Methodist Hospital

Recruiting

Brooklyn, New York, United States, 11215

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Mario Gaudino, Prof/PhD/MD

212-746-1812mfg9004@med.cornell.edu

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

New York Presbyterian Queens

Recruiting

Queens, New York, United States, 11355

Duke University

Recruiting

Durham, North Carolina, United States, 27710

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27106

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Genesis Healthcare System

Recruiting

Zanesville, Ohio, United States, 43701

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Lankenau Medical Center

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75204

The University of Texas Medical Health Branch at Galveston

Recruiting

Galveston, Texas, United States, 77550

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Mazankowski Alberta Heart Institute

Recruiting

Edmonton, Alberta, Canada

St. Boniface General Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Horizon Health Network - Saint John Regional Hospital

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

Newfoundland and Labrador Health Services

Recruiting

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

Health Sciences North

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

London Health Sciences

Recruiting

London, Ontario, Canada, N6A 5A5

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Sunnybrook Health Sciences

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

University Hospital of Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Recruiting

Ste Foy, Quebec, Canada, G1V 4G5

Hopital Sacre-Coeur

Recruiting

Montreal, Canada

Fraser Clinical Trials

Recruiting

New Westminster, Canada

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-04-01.