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Lay Description

This study compares different arterial graft configurations in women undergoing Coronary Artery Bypass Grafting (CABG).  Clinical outcomes and quality of life will be studied, with telephone followup every 6 months to study health outcomes including physical and mental well-being.

Category

  • Heart, Vascular and Blood
  • Womens Health
IRB Number
20220855HU
NCT Number
ct.gov registration not required
Open to Enrollment
Yes

Eligibility

Eligible Ages
-
Eligible Genders
Women
Accepts Healthy Volunteers
No

Inclusion Criteria

Adult women undergoing first-time isolated CABG

Exclusion Criteria

Patients undergoing concomitant procedures, reoperative CABG, who do not have adequate vein or second arterial conduits, or who have LVEF<35% with severely dilated cardiomyopathy.

Study Design

ROMA:WOMEN is a prospective un-blinded randomized multicenter clinical trial. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). All patients will receive a single internal thoracic artery (ITA) to the left anterior descending coronary artery (LAD). In the Multiple Arterial Graft group, the major vessel to the lateral wall will be grafted with a radial artery or a second ITA. The primary outcome will be a composite of death from any cause, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure in a cohort of 2,000 women randomized 1:1 to MAG or SAG. The secondary outcome will be the impact of MAG vs SAG on generic and disease-specific Quality of Life (QOL), and physical and mental health symptoms in women undergoing CABG.

Study Contact

Local Recruitment Point of Contact
Dawn Hui
(210) 867-7245
huid@uthscsa.edu

Principal Investigator
Dawn Hui