Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (NCT04124120)
Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
- Single arterial graft (PROCEDURE)
- Multiple arterial grafting (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (146 Sites)
Showing the first 25 of 146 sites.
- Cedars-Sinai Medical Center — Los Angeles, California
- Pomona Valley Hospital Medical Center — Pomona, California
- University of California, San Francisco — San Francisco, California
- University of Colorado — Aurora, Colorado
- Hartford Hospital — Hartford, Connecticut
- Yale University Hospital — New Haven, Connecticut
- Emory University — Atlanta, Georgia
- University of Chicago — Chicago, Illinois
- Indiana University — Indianapolis, Indiana
- University of Iowa — Iowa City, Iowa
- Johns Hopkins University — Baltimore, Maryland
- Baystate Health — Springfield, Massachusetts
- University of Massachusetts Chan Medical School — Worcester, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Corewell Health William Beaumont University Hospital — Royal Oak, Michigan
- Washington University in St. Louis — St Louis, Missouri
- Nebraska Heart Hospital — Lincoln, Nebraska
- Methodist Physicians Health — Omaha, Nebraska
- University of Nebraska Medical Center — Omaha, Nebraska
- Englewood Health — Englewood, New Jersey
- Newark Beth Israel Medical Center — Newark, New Jersey
- The Valley Hospital — Ridgewood, New Jersey
- NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York
- Weill Cornell Medicine — New York, New York
- Columbia University Medical Center — New York, New York
📞 Contact the Study Coordinator
Phone: (212) 746-1812
Email: mfg9004@med.cornell.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.