Single versus multiple arterial grafts for coronary bypass

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ROMA is a prospective, unblinded, randomized multicenter trial enrolling at least 4,300 patients undergoing primary, non-emergency isolated CABG across international centers. Participants are randomized 1:1 to receive either a single arterial graft (SAG) or multiple arterial grafts (MAG), with permuted block randomization stratified by center and type of second arterial graft. The primary endpoint is a composite of death from any cause, any stroke, post-discharge myocardial infarction, and repeat revascularization, and the trial is event-driven. Key exclusions include age over 70, left ventricular ejection fraction below 35%, emergency or repeat operations, severe end-organ dysfunction, active cancer, or lack of suitable conduit vessels.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.

Exclusion Criteria:

* Age \> 70 years
* Single graft
* Emergency operation
* Evolving myocardial infarction within 48 hours of surgery
* Left ventricular ejection fraction of \< 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 reduce 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 it's running

• University of Colorado
  Boulder, Colorado, United States Recruiting
• Baystate Health
  Springfield, Massachusetts, United States Recruiting
• Nebraska Heart Hospital
  Lincoln, Nebraska, United States Recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• NewYork-Presbyterian Brooklyn Methodist Hospital
  Brooklyn, New York, United States Recruiting
• Icahn School of Medicine, Mount Sinai
  New York, New York, United States Recruiting

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Mario Gaudino, MD — Weill Medical College of Cornell University
• Study coordinator: Mario Gaudino, MD
• Email: mfg9004@med.cornell.edu
• Phone: 212.746.1812

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.