Condition: Heart Diseases · Coronary Artery Disease · Coronary Artery Bypass Grafting · Sponsor: Weill Medical College of Cornell University
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…
This description comes directly from the study's public registry record.
Mario Gaudino, Prof/PhD/MD · 212.746.1812 · mfg9004@med.cornell.edu
Stephen Fremes, Prof/MD · 1 416 480 6073 · stephen.fremes@sunnybrook.ca
Always discuss trial participation with your own doctor first.
| 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 |
| Emory University | Atlanta, Georgia, United States | Recruiting |
| University of Chicago | Chicago, Illinois, United States | Recruiting |
| Indiana University | Indianapolis, Indiana, United States | Recruiting |
| University of Iowa | Iowa City, Iowa, United States | Recruiting |
| Johns Hopkins University | Baltimore, Maryland, United States | Recruiting |
| Baystate Health | Springfield, Massachusetts, United States | Recruiting |
+ 134 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04124120