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

Risk of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting: A Prospective Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07643194
Acronym
OPCAB-POCD
Enrollment
600
Registered
2026-06-11
Start date
2026-05-24
Completion date
2026-12-15
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction (POCD)

Keywords

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

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.

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.

Interventions

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.

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative Cognitive DysfunctionPostoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7Postoperative 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.

Secondary

MeasureTime frameDescription
Change in Montreal Cognitive Assessment ScorePostoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7The 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.
Length of Intensive Care Unit Staythrough ICU discharge, an average of 3 daysThe 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.
Length of Postoperative Hospital Staythrough hospital discharge, an average of 7 daysThe length of postoperative hospital stay will be recorded as the number of days from the date of surgery to the date of hospital discharge.
Incidence of Postoperative Complicationsthrough hospital discharge, an average of 7 daysPostoperative complications during hospitalization will be recorded, including cardiovascular, respiratory, neurological, renal, infectious, thromboembolic, and wound-related complications.
Duration of Postoperative Mechanical Ventilationthrough ICU stay, an average of 3 daysThe duration of postoperative mechanical ventilation will be recorded as the time from postoperative intensive care unit admission to successful discontinuation of mechanical ventilation.
Incidence of Postoperative Nausea and Vomitingthrough hospital discharge, an average of 7 daysPostoperative nausea and vomiting during the postoperative hospitalization period will be recorded based on medical records.
Incidence of In-Hospital Mortalitythrough hospital discharge, an average of 7 daysIn-hospital mortality will be recorded as death from any cause during the postoperative hospitalization period.

Countries

China

Contacts

CONTACTWenjun Liu, PhD
lwjchina@163.com+86 13811258408
CONTACTXuefei Jia, phD
jiaxuefei0320@163.com+86 13121380377
PRINCIPAL_INVESTIGATORWenjun Liu, PhD

Beijing Anzhen Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026