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

NCT07599553 | Not Yet Recruiting DMC

• 1 other identifier: 20260183-01H
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Graft Patency

Keywords

bypass graft harvesting; skeletonized harvesting; non-skeletonized harvesting; CABG surgery; Left Internal Mammary Artery; LIMA

Outcome Measures

Primary Outcomes (1)

• Feasibility of Implementation

  Combined assessment of screening, recruitment, randomization, surgical protocol adherence, and completion of study data collection and follow up procedures.

  2 years

Secondary Outcomes (4)

• Recruitment Rate

  Activation of study to 6 months.

• Protocol Adherence

  activation to 2 years per participant.

• Completeness of Study Data Collection

  activation to 2 years per participant.

• Completion of CTA at 1 year.

  enrollment to 1 year.

Study Arms (2)

Skeletonized Harvesting of LIMA

EXPERIMENTAL

LIMA is harvested using the skeletonized harvesting technique. This technique isolates the artery without the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.

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

Non-Skeletonized Harvesting of LIMA

ACTIVE COMPARATOR

LIMA is harvested using the non-skeletonized harvesting technique. This technique isolates the artery with the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.

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

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.

Non-Skeletonized Harvesting of LIMA; Skeletonized Harvesting of LIMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft.
• Provision of written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Population Health Research Institute: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Study Officials

• Fraser Rubens, MD, MSc.

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahya Awada, BSN, MCR, Ph.D.

CONTACT

613-696-7000; naawada@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data collectors, Research coordinators, CTA core laboratory readers, trial statisticians. Only the operating surgeon and operating room staff will be unblinded to the treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization to one of two blinded study interventions

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-04

Locations

CA (1)