Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWeill Medical College of Cornell University
About this trial
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 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). Differences by important subgroups (as defined above) will also be evaluated.
Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG.
Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG.
Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women patients ≥18 years old.
Isolated coronary artery bypass grafting.
Primary (first time) cardiac surgery procedure.
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.
Disqualifiers
Male gender
Single graft
Emergency operation
Myocardial infarction within 72 hours of surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Single arterial graft
Procedure/SurgeryThis interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
Multiple arterial grafting
Procedure/SurgeryThis intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.
Treatment groups
2,300 Participants
are divided into 2 treatment groupsGroup A: Single Arterial Graft (SAG) groupExperimental treatment 1 intervention
Group B: Multiple Arterial Graft (MAG) groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.
Time frame
Postoperatively, minimum 2.5 year follow-up2
Primary outcome for aim 2: Disease-specific quality of life
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.
Time frame
Postoperatively, minimum 2.5 year follow-upSecondary outcomes
1
Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization.
One of the secondary outcomes for aim 1: It will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), and repeat revascularization. This is the primary outcome of the parent ROMA trial.
Time frame
Postoperatively, minimum 2.5 year follow-up2
Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
Another secondary outcome for aim 1: It will be a composite of the first occurrence of death from cardiac cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure.
Time frame
Postoperatively, minimum 2.5 year follow-up3
Death from any cause
Another secondary outcome for aim 1: Death will be considered to be cardiac unless a definite non-cardiac cause is identified.
Time frame
Postoperatively, minimum 2.5 year follow-up4
Stroke
Another secondary outcome for aim 1: Based on the American Heart Association/American Stroke Association Expert Consensus stroke definition, stroke will be identified in case of: 1. pathological, imaging, or other objective evidence of cerebral ischemic injury in a defined vascular distribution; OR 2. clinical evidence of cerebral ischemic injury based on symptoms persisting ≥24 hours or until death, and other etiologies excluded.
Time frame
Postoperatively, minimum 2.5 year follow-upOther outcomes
1
Other recorded outcomes (safety endpoints)
30-day mortality and major postoperative complications (revision for bleeding, perioperative MI (\<48 hours after surgery), need for dialysis, need for tracheostomy, and surgical site complications).
Time frame
Within 30 days of surgery or during index hospitalization, whichever is longer.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
New York Presbyterian Hospital
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
Cedars-Sinai Medical Center
Collaborator
Columbia University
Collaborator
Duke University
Collaborator
Source ClinicalTrials.gov