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

Pilot Study for COMFORT Trial Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07599553

Acronym

COMFORT pilot

Enrollment

Registered

2026-05-20

Start date

2026-08-31

Completion date

2028-06-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Patency

Keywords

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

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.

Detailed description

Prior to expansion of the COMFORT Trial to multiple centres, a pilot phase will be conducted at UOHI to evaluate the feasibility of implementing the study protocol within the local clinical and research environment. Conducting an initial pilot phase allows the study team to assess the practical aspects of trial implementation, including patient screening and recruitment, informed consent procedures, randomization workflow, intraoperative documentation of the harvesting technique, and completion of study data collection. The pilot phase will also allow evaluation of study logistics related to follow-up procedures, including postoperative data collection and coordination of protocol-mandated computed tomography angiography (CTA). This process will help identify and address any operational challenges prior to broader trial implementation across participating centres. Participants enrolled during the pilot phase will undergo the same randomized study procedures described in the main COMFORT Trial protocol. Data collected during this phase may contribute to the overall COMFORT Trial dataset, subject to confirmation that the pilot procedures align with the finalized trial protocol and statistical analysis plan.

Interventions

PROCEDURESkeletonized 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Data collectors, Research coordinators, CTA core laboratory readers, trial statisticians. Only the operating surgeon and operating room staff will be unblinded to the treatment.

Intervention model description

1:1 randomization to one of two blinded study interventions

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Completeness of Study Data Collection	activation to 2 years per participant.	Measurement of ability to collect all protocol-required data.
Completion of CTA at 1 year.	enrollment to 1 year.	Feasibility of completing the CTA at 1 year for all participants.
Recruitment Rate	Activation of study to 6 months.	Measurement of rate of participant enrollment to determine ability to efficiently recruit into the main trial.
Protocol Adherence	activation to 2 years per participant.	Ability to complete all protocol required tests and assessments.

Countries

Canada

Contacts

CONTACTNahya Awada, BSN, MCR, Ph.D.

naawada@ottawaheart.ca613-696-7000

PRINCIPAL_INVESTIGATORFraser Rubens, MD, MSc.

Ottawa Heart Institute Research Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026