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NCT07599553
Study of Feasibility for Surgical Patients Undergoing Heart Surgery With the Mammary Arteries: Reviewing Infection, Occlusion Rates and Pain Assessments.
Conditions: Graft Patency
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: Ottawa Heart Institute Research Corporation
Location: University of Ottawa Heart Institute Ottawa Ontario
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 Criteria
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) \
Source: ClinicalTrials.gov (NCT07599553). StuddyBuddy aggregates publicly available trial information.