Study of Feasibility for Surgical Patients Undergoing Heart Surgery With the Mammary Arteries: Reviewing Infection, Occlusion Rates and Pain Assessments. (COMFORT pilot)
Pilot Study for COMFORT Trial Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Nahya Awada, BSN, MCR, Ph.D.
- Telefoonnummer: 613-696-7000
- E-mail: naawada@ottawaheart.ca
Studie Locaties
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Ontario
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Ottawa, Ontario, Canada, K1Y 4W7
- Werving
- University of Ottawa Heart Institute
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Contact:
- Nahya Awada, BSN, MCR, Ph.D.
- Telefoonnummer: 613-696-7000
- E-mail: naawada@ottawaheart.ca
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Skeletonized Harvesting of LIMA
LIMA is harvested using the skeletonized harvesting technique.
This technique isolates the artery without the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.
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This intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery.
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Actieve vergelijker: Non-Skeletonized Harvesting of LIMA
LIMA is harvested using the non-skeletonized harvesting technique.
This technique isolates the artery with the surrounding satellite veins, endothoracic fascia, and intercoastal nerves.
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This intervention is the surgical technique used to harvest the artery that will be used to perform the bypass surgery.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility of Implementation
Tijdsspanne: 2 years
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Combined assessment of screening, recruitment, randomization, surgical protocol adherence, and completion of study data collection and follow up procedures.
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2 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Recruitment Rate
Tijdsspanne: Activation of study to 6 months.
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Measurement of rate of participant enrollment to determine ability to efficiently recruit into the main trial.
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Activation of study to 6 months.
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Protocol Adherence
Tijdsspanne: activation to 2 years per participant.
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Ability to complete all protocol required tests and assessments.
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activation to 2 years per participant.
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Completeness of Study Data Collection
Tijdsspanne: activation to 2 years per participant.
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Measurement of ability to collect all protocol-required data.
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activation to 2 years per participant.
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Completion of CTA at 1 year.
Tijdsspanne: enrollment to 1 year.
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Feasibility of completing the CTA at 1 year for all participants.
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enrollment to 1 year.
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Fraser Rubens, MD, MSc., Ottawa Heart Institute Research Corporation
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 20260183-01H
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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