Cohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting

Официальное название

Risk of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting: A Prospective Cohort Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Off-Pump Coronary Artery Bypass Grafting
  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.

Первичные конечные точки

• Incidence of Postoperative Cognitive Dysfunction [Срок оценки: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7]

Вторичные конечные точки (7)

• Change in Montreal Cognitive Assessment Score [Срок оценки: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7]
• Length of Intensive Care Unit Stay [Срок оценки: through ICU discharge, an average of 3 days]
• Length of Postoperative Hospital Stay [Срок оценки: through hospital discharge, an average of 7 days]
• Incidence of Postoperative Complications [Срок оценки: through hospital discharge, an average of 7 days]
• Duration of Postoperative Mechanical Ventilation [Срок оценки: through ICU stay, an average of 3 days]
• Incidence of Postoperative Nausea and Vomiting [Срок оценки: through hospital discharge, an average of 7 days]
• Incidence of In-Hospital Mortality [Срок оценки: through hospital discharge, an average of 7 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing Anzhen Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07643194 · POCD-MOCA-2026-001 · L252086 · KS2025225

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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