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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nahya Awada, BSN, MCR, Ph.D.
- Número de teléfono: 613-696-7000
- Correo electrónico: naawada@ottawaheart.ca
Ubicaciones de estudio
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Ontario
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Ottawa, Ontario, Canadá, K1Y 4W7
- Reclutamiento
- University of Ottawa Heart Institute
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Contacto:
- Nahya Awada, BSN, MCR, Ph.D.
- Número de teléfono: 613-696-7000
- Correo electrónico: naawada@ottawaheart.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of Implementation
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Fraser Rubens, MD, MSc., Ottawa Heart Institute Research Corporation
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 20260183-01H
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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