Comparing Single vs. Multiple Arterial Grafts in Women for Heart Disease
This study, called ROMA:Women, is looking at how different surgical approaches for coronary artery bypass grafting (CABG) affect women with heart disease. CABG is a surgery to improve blood flow to the heart. Researchers want to see if using multiple arterial grafts (where more than one artery is used to bypass blockages) leads to better outcomes and quality of life compared to using a single arterial graft (where one artery and other veins are used). You might be able to join if you are a woman aged 18 or older, having your first heart surgery for isolated coronary artery bypass grafting, and have significant disease in certain heart arteries. The study will measure things like death, stroke, heart attacks, repeat surgeries, and hospital readmissions, as well as your quality of life, for at least 2.5 years after surgery.
- Study design
- This is an interventional study that plans to enroll 2,300 women. Participants will be randomly assigned to receive either a single arterial graft or multiple arterial grafts.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 2.5 years after their surgery to assess outcomes and quality of life.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
At a glance
Conditions
Where it's being run
146 sites across 62 statesStudy leadership
- Mario Gaudino, Prof/PhD/MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
- Stephen Fremes, MD · PRINCIPAL_INVESTIGATOR · Sunnybrook Health Sciences Centre
- Ruth Masterson Creber, RN, PhD · PRINCIPAL_INVESTIGATOR · Columbia University
- C. Noel Bairey Merz, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai
- Karla Ballman, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
- Sean O'Brien, PhD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.Postoperatively, minimum 2.5 year follow-up
The primary outcome for aim 1 will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
- Primary outcome for aim 2: Disease-specific quality of lifePostoperatively, minimum 2.5 year follow-up
Assessed using the Seattle Angina Questionnaire (SAQ), a validated 19-item questionnaire that measures five domains related to coronary disease: angina frequency, physical limitations, quality of life, angina stability, and treatment satisfaction. Scores range from 0 to 100 with higher scores indicating fewer symptoms and better health status. The minimum clinically important difference on the SAQ is 5 points. The primary endpoint for aim 2 is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline.