What is the Purpose of this Study?
The purpose of this study is to determine the effect of single versus multiple arterial revascularization (the restoration of blood flow to an organ) for female patients undergoing coronary artery bypass surgery. Currently, an artery is used for the first graft, and either an artery or a vein is used for the second graft. Researchers aim to determine whether one method is better than the other.
Participants will be randomly assigned to 1 of 2 study groups: single arterial grafting (SAG) vs. multiple arterial grafting (MAG). In the SAG group, only veins will be used for the secondary bypass grafts. (Commonly, the saphenous vein is used.) In the MAG group, an artery may be used for the second graft, and either an artery or a vein may be used for additional grafts. All participants will receive a graft using the left internal thoracic artery; it has been established that using a left internal thoracic artery graft improves outcomes in patients undergoing coronary artery bypass surgery.
Eligibility
- 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.
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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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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA WOMEN trial.