Cohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting (OPCAB-POCD)

June 9, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Beijing Anzhen Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Cognitive Dysfunction
Time Frame: 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.
Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montreal Cognitive Assessment Score
Time Frame: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
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.
Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
Length of Intensive Care Unit Stay
Time Frame: through ICU discharge, an average of 3 days
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.
through ICU discharge, an average of 3 days
Length of Postoperative Hospital Stay
Time Frame: through hospital discharge, an average of 7 days
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.
through hospital discharge, an average of 7 days
Incidence of Postoperative Complications
Time Frame: through hospital discharge, an average of 7 days
Postoperative complications during hospitalization will be recorded, including cardiovascular, respiratory, neurological, renal, infectious, thromboembolic, and wound-related complications.
through hospital discharge, an average of 7 days
Duration of Postoperative Mechanical Ventilation
Time Frame: through ICU stay, an average of 3 days
The duration of postoperative mechanical ventilation will be recorded as the time from postoperative intensive care unit admission to successful discontinuation of mechanical ventilation.
through ICU stay, an average of 3 days
Incidence of Postoperative Nausea and Vomiting
Time Frame: through hospital discharge, an average of 7 days
Postoperative nausea and vomiting during the postoperative hospitalization period will be recorded based on medical records.
through hospital discharge, an average of 7 days
Incidence of In-Hospital Mortality
Time Frame: through hospital discharge, an average of 7 days
In-hospital mortality will be recorded as death from any cause during the postoperative hospitalization period.
through hospital discharge, an average of 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Investigators

  • Principal Investigator: Wenjun Liu, PhD, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 24, 2026

Primary Completion (Estimated)

November 24, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

May 24, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POCD-MOCA-2026-001
  • L252086 (Other Grant/Funding Number: Beijing Natural Science Foundation)
  • KS2025225 (Other Identifier: Ethics Committee of Beijing Anzhen Hospital, Capital Medical University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy, ethical, and institutional data protection considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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