Study of Feasibility for Surgical Patients Undergoing Heart Surgery With the Mammary Arteries: Re… (NCT07599553) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of Feasibility for Surgical Patients Undergoing Heart Surgery With the Mammary Arteries: Reviewing Infection, Occlusion Rates and Pain Assessments.
Canada35 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Implementation
Timeframe: 2 years
Trial details
NCT IDNCT07599553
SponsorOttawa Heart Institute Research Corporation