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ROMA:WOMEN Details

group of scientists discussing the trial

Trial Information

Principal Investigator: Mario Gaudino, M.D.
ClinicalTrials.gov Identifier: NCT04124120
Status: Active
Patient Accrual: Open to Accrual

Hypotheses

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) in women.

Objective

  1. The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more arterial grafts (AGs) compared to a single arterial graft (SAG) is associated with a reduction in the composite outcome 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 in women undergoing CABG .
  2. The secondary aim is to 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 and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL).

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

  1. Male gender
  2. Single graft
  3. Emergency operation
  4. Myocardial infarction within 72 hours of surgery
  5. Left ventricular ejection fraction < 35%
  6. Any concomitant cardiac or non-cardiac procedure
  7. Previous cardiac surgery
  8. Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.
  9. Inability to use the saphenous vein or either the radial or the right internal thoracic arteries
  10. Anticipated need for coronary thrombo-endarterectomy
  11. Planned hybrid revascularization

The ROMA:WOMEN Trial

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