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

NCT07643194 | Not Yet Recruiting

• 3 other identifiers: POCD-MOCA-2026-001L252086KS2025225
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Cognitive Dysfunction (POCD)

Keywords

Postoperative Cognitive Dysfunction; Off-Pump Coronary Artery Bypass Grafting; OPCABG; Montreal Cognitive Assessment; Prospective Cohort Study

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Cognitive Dysfunction

  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 Outcomes (7)

• Change in Montreal Cognitive Assessment Score

  Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7

• Length of Intensive Care Unit Stay

  through ICU discharge, an average of 3 days

• Length of Postoperative Hospital Stay

  through hospital discharge, an average of 7 days

• Incidence of Postoperative Complications

  through hospital discharge, an average of 7 days

• Duration of Postoperative Mechanical Ventilation

  through ICU stay, an average of 3 days

Study Arms (1)

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

Interventions

Off-Pump Coronary Artery Bypass Grafting PROCEDURE

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.

Off-Pump Coronary Artery Bypass Grafting Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Wenjun Liu, PhD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjun Liu, PhD

CONTACT

+86 13811258408; lwjchina@163.com

Xuefei Jia, phD

CONTACT

+86 13121380377; jiaxuefei0320@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 11, 2026
• Study Start: May 24, 2026
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)