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

NCT07599553 · tracked via the Priya Life Science Canada tracker

Sponsor

Ottawa Heart Institute Research Corporation

Phase

Not applicable

Started

2026-08-31

Last updated

2026-09-08

Condition(s) studied

Graft Patency

Investigational drug(s) / intervention(s)

Skeletonized vs non-skeletonized harvesting of the left internal mammary artery

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

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Feasibility of Implementation — 2 years
Combined assessment of screening, recruitment, randomization, surgical protocol adherence, and completion of study data collection and follow up procedures.

Trial sites (1)

Facility	City	Region	Status
University of Ottawa Heart Institute	Ottawa	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07599553 on ClinicalTrials.gov ↗ ← All trials in Canada