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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
600
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Wenjun Liu, PhD
- 電話番号：+86 13811258408
- メール：lwjchina@163.com
研究連絡先のバックアップ
- 名前：Xuefei Jia, phD
- 電話番号：+86 13121380377
- メール：jiaxuefei0320@163.com
研究場所
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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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コンタクト：
- Wenjun Liu, PhD
- 電話番号：+86 13811258408
- メール：lwjchina@163.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Postoperative Cognitive Dysfunction
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Montreal Cognitive Assessment Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Wenjun Liu, PhD、Beijing Anzhen Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月24日
一次修了 (推定)
2026年11月24日
研究の完了 (推定)
2026年12月15日
試験登録日
最初に提出
2026年5月24日
QC基準を満たした最初の提出物
2026年6月9日
最初の投稿 (実際)
2026年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月11日
QC基準を満たした最後の更新が送信されました
2026年6月9日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- POCD-MOCA-2026-001
- L252086 (その他の助成金/資金番号：Beijing Natural Science Foundation)
- KS2025225 (その他の識別子：Ethics Committee of Beijing Anzhen Hospital, Capital Medical University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared due to privacy, ethical, and institutional data protection considerations.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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