Cohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting (OPCAB-POCD)
2026年6月9日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (估计的)
600
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Wenjun Liu, PhD
- 电话号码：+86 13811258408
- 邮箱：lwjchina@163.com
研究联系人备份
- 姓名：Xuefei Jia, phD
- 电话号码：+86 13121380377
- 邮箱：jiaxuefei0320@163.com
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100029
- Beijing Anzhen Hospital, Capital Medical University
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接触：
- Wenjun Liu, PhD
- 电话号码：+86 13811258408
- 邮箱：lwjchina@163.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Postoperative Cognitive Dysfunction
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Montreal Cognitive Assessment Score
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Wenjun Liu, PhD、Beijing Anzhen Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月24日
初级完成 (估计的)
2026年11月24日
研究完成 (估计的)
2026年12月15日
研究注册日期
首次提交
2026年5月24日
首先提交符合 QC 标准的
2026年6月9日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年6月11日
上次提交的符合 QC 标准的更新
2026年6月9日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- POCD-MOCA-2026-001
- L252086 (其他赠款/资助编号：Beijing Natural Science Foundation)
- KS2025225 (其他标识符：Ethics Committee of Beijing Anzhen Hospital, Capital Medical University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared due to privacy, ethical, and institutional data protection considerations.
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.