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

Part of paid clinical trials in Los Angeles, California.

Sponsor: Weill Medical College of Cornell University
Study ID: NCT04124120
Status: Recruiting

Apply to this trial

Conditions

Coronary Artery Bypass Grafting
Coronary Artery Disease
Heart Diseases

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Single arterial graft — PROCEDURE
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 — PROCEDURE
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 Details

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.

Key Dates

Start date: Apr 17, 2023
Status verified: Mar 2026
Primary completion: Mar 31, 2030
Completion: Mar 31, 2030

Study Design

Enrollment: 2,300 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 ]

Central Contacts

Mario Gaudino, Prof/PhD/MD
212.746.1812
[email protected]
Stephen Fremes, Prof/MD
1 416 480 6073
[email protected]

Locations (42)

Facility	City	State	ZIP	Site coordinators
Cedars-Sinai Medical Center	Los Angeles	California	90048	Joanna Chikwe, MD
Pomona Valley Hospital Medical Center	Pomona	California	91767	Christine Montesa, MD
University of California, San Francisco	San Francisco	California	94118	Elaine Tseng, MD
University of Colorado	Aurora	Colorado	80045	Jessica Rove, MD
Hartford Hospital	Hartford	Connecticut	06106	David Yaffee, MD
Yale University Hospital	New Haven	Connecticut	06510	Roland Assi, MD
Emory University	Atlanta	Georgia	30322	John Puskas, MD
University of Chicago	Chicago	Illinois	60637	Hasam Balkhy, MD
Indiana University	Indianapolis	Indiana	46202	Lola Chabtini, MD
University of Iowa	Iowa City	Iowa	52242	Mohammad Bashir, MD
Johns Hopkins University	Baltimore	Maryland	21218	Jennifer Lawton, MD
Baystate Health	Springfield	Massachusetts	01199	Daniel Engelman, MD
University of Massachusetts Chan Medical School	Worcester	Massachusetts	01655	-
University of Michigan	Ann Arbor	Michigan	48104	Robert Hawkins, MD
Corewell Health William Beaumont University Hospital	Royal Oak	Michigan	48073	Thomas Schwann, MD
Washington University in St. Louis	St Louis	Missouri	63110	Puja Kachroo, MD
Nebraska Heart Hospital	Lincoln	Nebraska	68526	Omar Nass
Methodist Physicians Health	Omaha	Nebraska	68118	HelenMari Merritt-Genore, DO
University of Nebraska Medical Center	Omaha	Nebraska	68198	Aleem Siddique, MD
Englewood Health	Englewood	New Jersey	07631	Molly Schultheis, MD
Newark Beth Israel Medical Center	Newark	New Jersey	07112	Arash Salemi, MD
The Valley Hospital	Ridgewood	New Jersey	07450	Juan B Grau, MD
NewYork-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York	11215	Sandhya Balaram, MD
Columbia University Medical Center	New York	New York	10032	Koji Takeda, MD
Lenox Hill Hospital	New York	New York	10075	Nirav Patel, MD
Weill Cornell Medicine	New York	New York	10021	Mario Gaudino, Prof/PhD/MD [email protected] 212-746-1812
New York Presbyterian Queens	Queens	New York	11355	Charles Mack, MD
Duke University	Durham	North Carolina	27710	Brittany Zwischenberger, MD
East Carolina University	Greenville	North Carolina	27858	Benjamin Degner, MD
Wake Forest University	Winston-Salem	North Carolina	27106	Bart Imielski, MD
Cleveland Clinic Foundation	Cleveland	Ohio	44195	Faisal Bakaeen, MD
Ohio State University	Columbus	Ohio	43210	Jovan Bozinovski, MD
Genesis Healthcare System	Zanesville	Ohio	43701	Surender Neravetla, MD
University of Pennsylvania	Philadelphia	Pennsylvania	19104	Marisa Cevasco, MD
Allegheny General Hospital	Pittsburgh	Pennsylvania	15212	Scott Halbreiner, MD
Lankenau Medical Center	Wynnewood	Pennsylvania	19096	Gianluca Torregrossa, MD
Rhode Island Hospital	Providence	Rhode Island	02903	Neel Sodha, MD
Baylor Scott & White Research Institute	Dallas	Texas	75204	Michael DiMaio, MD
The University of Texas Medical Health Branch at Galveston	Galveston	Texas	77550	Andre Son, MD
Baylor College of Medicine	Houston	Texas	77030	Lauren Barron, MD
UT Health San Antonio	San Antonio	Texas	78229	Dawn Hui, MD
University of Utah	Salt Lake City	Utah	84132	Matthew Goodwin, MD

Find similar trials in Los Angeles, CA

By research site

Cedars-Sinai Medical Center· Los Angeles, CA Pomona Valley Hospital Medical Center· Pomona, CA University of California, San Francisco· San Francisco, CA University of Colorado· Aurora, CO Hartford Hospital· Hartford, CT Yale University Hospital· New Haven, CT

Related Studies

The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic Testing
Recruiting · University of Chicago · Chicago, Illinois
Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells
Enrolling By Invitation · Scripps Translational Science Institute · La Jolla, California
Product Surveillance Registry
Recruiting · Medtronic · Birmingham, Alabama
Factors Affect Outcomes in Cardiovascular Surgery
Recruiting · University of California, Davis · Sacramento, California