Cohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting (OPCAB-POCD)
2026년 6월 9일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (추정된)
600
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Wenjun Liu, PhD
- 전화번호: +86 13811258408
- 이메일: lwjchina@163.com
연구 연락처 백업
- 이름: Xuefei Jia, phD
- 전화번호: +86 13121380377
- 이메일: jiaxuefei0320@163.com
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100029
- Beijing Anzhen Hospital, Capital Medical University
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연락하다:
- Wenjun Liu, PhD
- 전화번호: +86 13811258408
- 이메일: lwjchina@163.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Postoperative Cognitive Dysfunction
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Montreal Cognitive Assessment Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Wenjun Liu, PhD, Beijing Anzhen Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 24일
기본 완료 (추정된)
2026년 11월 24일
연구 완료 (추정된)
2026년 12월 15일
연구 등록 날짜
최초 제출
2026년 5월 24일
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
2026년 6월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- POCD-MOCA-2026-001
- L252086 (기타 보조금/기금 번호: Beijing Natural Science Foundation)
- KS2025225 (기타 식별자: Ethics Committee of Beijing Anzhen Hospital, Capital Medical University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared due to privacy, ethical, and institutional data protection considerations.
약물 및 장치 정보, 연구 문서
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .