Cohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting (OPCAB-POCD)
9 de junio de 2026 actualizado por: Beijing Anzhen Hospital
Risk of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting: A Prospective Cohort Study
This prospective cohort study aims to investigate postoperative cognitive dysfunction in patients undergoing off-pump coronary artery bypass grafting.
Eligible patients will be enrolled before surgery and followed after surgery.
Cognitive function will be assessed using the Montreal Cognitive Assessment before surgery and at predefined postoperative time points.
Perioperative clinical information, including preoperative assessment data, intraoperative monitoring parameters, and postoperative clinical data, will be collected.
The study will evaluate the occurrence of postoperative cognitive dysfunction and explore its association with perioperative factors.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective observational cohort study of patients undergoing off-pump coronary artery bypass grafting. The study aims to investigate postoperative cognitive dysfunction and its association with perioperative clinical factors. Eligible patients will be enrolled before surgery and followed after surgery according to the study protocol.
Baseline information will be collected before surgery, including demographic characteristics, medical history, comorbidities, laboratory test results, and preoperative cognitive assessment. Intraoperative and postoperative data will also be collected, including anesthesia-related variables, surgical information, hemodynamic and monitoring parameters, postoperative clinical status, and relevant complications.
Cognitive function will be assessed before surgery and at predefined postoperative time points using standardized cognitive assessment tools, such as the Montreal Cognitive Assessment. Postoperative cognitive dysfunction will be determined according to the predefined criteria based on changes in cognitive assessment results from baseline to postoperative follow-up.
The study will describe the incidence of postoperative cognitive dysfunction after off-pump coronary artery bypass grafting and evaluate the association between perioperative factors and postoperative cognitive outcomes. The results may help improve understanding of postoperative cognitive dysfunction in this surgical population and provide evidence for perioperative risk assessment and clinical management.
Tipo de estudio
De observación
Inscripción (Estimado)
600
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Wenjun Liu, PhD
- Número de teléfono: +86 13811258408
- Correo electrónico: lwjchina@163.com
Copia de seguridad de contactos de estudio
- Nombre: Xuefei Jia, phD
- Número de teléfono: +86 13121380377
- Correo electrónico: jiaxuefei0320@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Beijing Anzhen Hospital, Capital Medical University
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Contacto:
- Wenjun Liu, PhD
- Número de teléfono: +86 13811258408
- Correo electrónico: lwjchina@163.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult patients scheduled to undergo elective off-pump coronary artery bypass grafting at Beijing Anzhen Hospital, Capital Medical University, will be prospectively enrolled.
Eligible patients must be able to complete preoperative cognitive assessments and provide informed consent.
Patients will be followed after surgery to evaluate postoperative cognitive dysfunction.
Descripción
Inclusion Criteria:
- Age 18 years or older
- Scheduled to undergo elective off-pump coronary artery bypass grafting
- American Society of Anesthesiologists physical status classification I to IV
- Able to complete preoperative cognitive assessments, including the Mini-Mental State Examination and the Montreal Cognitive Assessment
- Written informed consent provided by the patient or family member
Exclusion Criteria:
- Emergency surgery
- Pre-existing diagnosed cognitive impairment or history of psychiatric disease
- Preoperative cognitive impairment
- Severe neurological disease, such as sequelae of stroke, that may interfere with cognitive assessment
- Severe visual or hearing impairment that prevents completion of cognitive assessment
- Inability to understand Chinese or presence of language communication barriers
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Off-Pump Coronary Artery Bypass Grafting Cohort
Patients undergoing off-pump coronary artery bypass grafting who will receive preoperative cognitive assessment and postoperative follow-up for postoperative cognitive dysfunction.
Perioperative clinical information, including preoperative assessment data, intraoperative monitoring parameters, and postoperative clinical data, will be collected.
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Off-pump coronary artery bypass grafting is performed as part of routine clinical care for patients with coronary artery disease.
The study protocol does not assign participants to this procedure or to any additional intervention.
This observational study will collect perioperative clinical data and follow patients after surgery to assess postoperative cognitive dysfunction.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Postoperative Cognitive Dysfunction
Periodo de tiempo: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
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Postoperative cognitive dysfunction will be evaluated by comparing postoperative Montreal Cognitive Assessment scores with preoperative baseline scores.
Preoperative cognitive function will be assessed using the Montreal Cognitive Assessment 1 day after hospital admission.
Postoperative cognitive function will be assessed using the Montreal Cognitive Assessment on postoperative day 7 or, if the patient is discharged before postoperative day 7, 1 day before hospital discharge.
Postoperative cognitive dysfunction is defined as a decline in the postoperative Montreal Cognitive Assessment score of at least 1 standard deviation compared with the preoperative baseline score.
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Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Montreal Cognitive Assessment Score
Periodo de tiempo: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
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The change in Montreal Cognitive Assessment score will be calculated by comparing the postoperative score with the preoperative baseline score.
Preoperative cognitive function will be assessed 1 day after hospital admission, and postoperative cognitive function will be assessed on postoperative day 7 or, if the patient is discharged before postoperative day 7, 1 day before hospital discharge.
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Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
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Length of Intensive Care Unit Stay
Periodo de tiempo: through ICU discharge, an average of 3 days
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The length of intensive care unit stay will be recorded as the number of days from admission to the intensive care unit after surgery to discharge from the intensive care unit.
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through ICU discharge, an average of 3 days
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Length of Postoperative Hospital Stay
Periodo de tiempo: through hospital discharge, an average of 7 days
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The length of postoperative hospital stay will be recorded as the number of days from the date of surgery to the date of hospital discharge.
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through hospital discharge, an average of 7 days
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Incidence of Postoperative Complications
Periodo de tiempo: through hospital discharge, an average of 7 days
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Postoperative complications during hospitalization will be recorded, including cardiovascular, respiratory, neurological, renal, infectious, thromboembolic, and wound-related complications.
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through hospital discharge, an average of 7 days
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Duration of Postoperative Mechanical Ventilation
Periodo de tiempo: through ICU stay, an average of 3 days
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The duration of postoperative mechanical ventilation will be recorded as the time from postoperative intensive care unit admission to successful discontinuation of mechanical ventilation.
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through ICU stay, an average of 3 days
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Incidence of Postoperative Nausea and Vomiting
Periodo de tiempo: through hospital discharge, an average of 7 days
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Postoperative nausea and vomiting during the postoperative hospitalization period will be recorded based on medical records.
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through hospital discharge, an average of 7 days
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Incidence of In-Hospital Mortality
Periodo de tiempo: through hospital discharge, an average of 7 days
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In-hospital mortality will be recorded as death from any cause during the postoperative hospitalization period.
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through hospital discharge, an average of 7 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Wenjun Liu, PhD, Beijing Anzhen Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
24 de mayo de 2026
Finalización primaria (Estimado)
24 de noviembre de 2026
Finalización del estudio (Estimado)
15 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
24 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
11 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- POCD-MOCA-2026-001
- L252086 (Otro número de subvención/financiamiento: Beijing Natural Science Foundation)
- KS2025225 (Otro identificador: Ethics Committee of Beijing Anzhen Hospital, Capital Medical University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared due to privacy, ethical, and institutional data protection considerations.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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