Randomization of Single vs Multiple Arterial Grafts
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWeill Medical College of Cornell University
About this trial
The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.
Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
Disqualifiers
Age > 70 years
Single graft
Emergency operation
Evolving myocardial infarction within 48 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
4,300 Participants
are divided into 2 treatment groupsGroup A: Single Arterial GroupExperimental treatment 1 intervention
Group B: Multiple Arterial GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Composite Outcome
A composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.
Time frame
> 72 hours after surgery and/or repeat revascularizationSecondary outcomes
1
30-day mortality
Death from any cause at 30-days
Time frame
30 days post-operatively2
Major postoperative complications
Revision for bleeding, perioperative myocardial infarction, any stroke, need for dialysis, need for tracheostomy, and surgical site infection.
Time frame
In-hospital stay, up to 30 days post-operatively3
Sternal wound complication
Wound drainage, skin separation, unstable sternum, and sternal dehiscence, infection
Time frame
6 months post-operatively4
Composite Outcome of Death from any cause
A composite of death from any cause, post discharge myocardial infarction,stroke, and/or repeat revascularization
Time frame
Analysis will be performed after 631 events. The investigators assume this will occur at a mean follow-up of 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov