Cohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting (OPCAB-POCD)
9 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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 estudo
Observacional
Inscrição (Estimado)
600
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Wenjun Liu, PhD
- Número de telefone: +86 13811258408
- E-mail: lwjchina@163.com
Estude backup de contato
- Nome: Xuefei Jia, phD
- Número de telefone: +86 13121380377
- E-mail: jiaxuefei0320@163.com
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100029
- Beijing Anzhen Hospital, Capital Medical University
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Contato:
- Wenjun Liu, PhD
- Número de telefone: +86 13811258408
- E-mail: lwjchina@163.com
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Postoperative Cognitive Dysfunction
Prazo: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
|
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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Montreal Cognitive Assessment Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Wenjun Liu, PhD, Beijing Anzhen Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
24 de maio de 2026
Conclusão Primária (Estimado)
24 de novembro de 2026
Conclusão do estudo (Estimado)
15 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
24 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de junho de 2026
Primeira postagem (Real)
11 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- POCD-MOCA-2026-001
- L252086 (Número de outro subsídio/financiamento: Beijing Natural Science Foundation)
- KS2025225 (Outro identificador: Ethics Committee of Beijing Anzhen Hospital, Capital Medical University)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be shared due to privacy, ethical, and institutional data protection considerations.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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