Comparing single and multiple arterial grafts in women with heart disease

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

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.

Why it matters

Who can join: the full rules

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 it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Pomona Valley Hospital Medical Center
  Pomona, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting
• Hartford Hospital
  Hartford, Connecticut, United States Recruiting
• Yale University Hospital
  New Haven, Connecticut, United States Recruiting

+96 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Mario Gaudino, Prof/PhD/MD — Weill Medical College of Cornell University
• Study coordinator: Mario Gaudino, Prof/PhD/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.