RECRUITING Not applicable ClinicalTrials.gov

Study of Feasibility for Surgical Patients Undergoing Heart Surgery With the Mammary Arteries: Reviewing Infection, Occlusion Rates and Pain Assessments.

Sponsor: Ottawa Heart Institute Research Corporation • ClinicalTrials.gov ID: NCT07599553

Registry updated: 2026-09-08

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Skeletonized vs non-skeletonized harvesting of the left internal mammary artery (Procedure)
This intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery.

Eligibility criteria

Inclusion Criteria: * Age 18 years or older * Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft. * Provision of written informed consent. Exclusion Criteria: * 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 * History of chronic sternal pain prior to the index surgery. * Known left subclavian artery stenosis (\>50%) * Previous radiation therapy to the chest * Known allergy or contraindication to iodinated contrast media that cannot be managed with premedication. * Estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2 at baseline (relative contraindications to CTA contrast). The eGFR will be determined by each participating institution according to their standard practice.

Conditions

Graft Patency

Locations

University of Ottawa Heart Institute — Ottawa, Ontario, Canada

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment