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

RecruitingNAAges 18 Years - anyFemaleWeill Medical College of Cornell University
NCT04124120 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 enro

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📋 Eligibility rules (as published)
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
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What it tests

  • Single arterial graft
  • Multiple arterial grafting
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Where

146 sites
Cedars-Sinai Medical Center
Los Angeles, United States
Pomona Valley Hospital Medical Center
Pomona, United States
University of California, San Francisco
San Francisco, United States
University of Colorado
Aurora, United States
Hartford Hospital
Hartford, United States
Yale University Hospital
New Haven, United States
Emory University
Atlanta, United States
University of Chicago
Chicago, United States

…and 138 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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