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Comparing single and multiple arterial grafts in women with heart disease

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

Not applicable Interventional Weill Medical College of Cornell University · NCT04124120

This study is testing whether using one or more artery grafts during heart surgery can lead to better health outcomes and quality of life for women with heart disease.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2300 (estimated)
Ages18 Years and up
SexFemale
SponsorWeill Medical College of Cornell University Academic / other
Locations146 sites (Los Angeles, California and 145 other locations)
Trial IDNCT04124120 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the outcomes of single arterial grafting (SAG) versus multiple arterial grafting (MAG) in women undergoing coronary artery bypass grafting (CABG). The study will enroll 2,000 women, randomly assigning them to either SAG or MAG to assess the impact on major adverse cardiac and cerebrovascular events, as well as quality of life. The trial will also evaluate differences in outcomes based on various clinical and surgical subgroups. By leveraging the existing infrastructure of the parent ROMA trial, this study seeks to provide robust data on the effectiveness of these two grafting techniques.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older who are undergoing isolated coronary artery bypass grafting for significant coronary artery disease.

Not a fit: Patients who may not benefit from this study include men, those requiring emergency surgery, or individuals with severe comorbidities that limit life expectancy.

Why it matters

Potential benefit: If successful, this study could lead to improved clinical outcomes and quality of life for women undergoing heart surgery.

How similar studies have performed: Previous studies have shown promising results with multiple arterial grafting, but this specific focus on women represents a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Los Angeles, California and 145 other locations

+96 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart DiseasesCoronary Artery DiseaseCoronary Artery Bypass Grafting
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.