About this trial
The Pilot study for the COMFORT Trial is a single centre trial to determine the feasibility of the full COMFORT Trial.
The main COMFORT Trial will be a multi-centre trial to investigate the coronary artery bypass grafting outcomes when harvesting the Left Internal Mammary Artery (LIMA) using a skeletonized approach (artery is isolated without the surrounding veins, fascia and nerves) compared to harvesting the LIMA using a non-skeletonized approach (artery is isolated with the surrounding veins, fascia and nerves). Harvesting the LIMA with the non-skeletonized approach is the standard technique. Participants will complete a Coronary Artery Tomography scan at 1 year to determine if the LIMA graft remains open. Follow up of the participants will continue until 2 years post surgery.
Eligibility criteria
Qualifiers
Age 18 years or older
Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft.
Provision of written informed consent.
Disqualifiers
Non-sternotomy surgical approach (e.g., minimally invasive, thoracotomy)
Emergency surgery (defined as surgery required within 24 hours or presentation
History of prior ternotomy
Currently receiving systemic antibiotics or with an active bacterial infection at the time of surgery
Trial design
Treatments tested in this trial
- Skeletonized vs non-skeletonized harvesting of the left internal mammary artery
Treatment groups
Sponsors and collaborators
Ottawa Heart Institute Research Corporation
Lead sponsor
Population Health Research Institute
Collaborator