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

ConditionGraft Patency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    This intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Skeletonized Harvesting of LIMAExperimental treatment 1 intervention
Group B: Non-Skeletonized Harvesting of LIMAActive comparator 1 intervention

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

1

Recruitment Rate

Measurement of rate of participant enrollment to determine ability to efficiently recruit into the main trial.

Time frame
Activation of study to 6 months.
2

Protocol Adherence

Ability to complete all protocol required tests and assessments.

Time frame
activation to 2 years per participant.
3

Completeness of Study Data Collection

Measurement of ability to collect all protocol-required data.

Time frame
activation to 2 years per participant.
4

Completion of CTA at 1 year.

Feasibility of completing the CTA at 1 year for all participants.

Time frame
enrollment to 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

Population Health Research Institute

Collaborator

Source ClinicalTrials.gov
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