Postoperative Cognitive Dysfunction (POCD)OPCAB-POCDNCT07643194
Cohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting
An observational study of Postoperative Cognitive Dysfunction (POCD), run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction (POCD)
- What is being tested?
- Off-Pump Coronary Artery Bypass Grafting
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2026to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Wenjun Liu, PhD, +86 13811258408, lwjchina@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Off-Pump Coronary Artery Bypass Grafting
- Keywords
- Postoperative Cognitive Dysfunction, Off-Pump Coronary Artery Bypass Grafting, OPCABG, Montreal Cognitive Assessment, Prospective Cohort Study
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-Pump Coronary Artery Bypass GraftingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Off-Pump Coronary Artery Bypass Grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
Secondary outcomes (7)
Change in Montreal Cognitive Assessment Score
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.
Measured: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
Length of Intensive Care Unit Stay
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.
Measured: through ICU discharge, an average of 3 days
Length of Postoperative Hospital Stay
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.
Measured: through hospital discharge, an average of 7 days
Incidence of Postoperative Complications
Postoperative complications during hospitalization will be recorded, including cardiovascular, respiratory, neurological, renal, infectious, thromboembolic, and wound-related complications.
Measured: through hospital discharge, an average of 7 days
Duration of Postoperative Mechanical Ventilation
The duration of postoperative mechanical ventilation will be recorded as the time from postoperative intensive care unit admission to successful discontinuation of mechanical ventilation.
Measured: through ICU stay, an average of 3 days
Incidence of Postoperative Nausea and Vomiting
Postoperative nausea and vomiting during the postoperative hospitalization period will be recorded based on medical records.
Measured: through hospital discharge, an average of 7 days
Incidence of In-Hospital Mortality
In-hospital mortality will be recorded as death from any cause during the postoperative hospitalization period.
Measured: through hospital discharge, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start24 May 2026 (estimated)
- Primary completion24 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive Dysfunction (POCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenjun Liu, PhD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643194
- Sponsor's protocol ID
- POCD-MOCA-2026-001
- Other IDs
- L252086, KS2025225
- Acronym
- OPCAB-POCD
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy, ethical, and institutional data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07643194
- Acronym / sponsor ID
- OPCAB-POCD / POCD-MOCA-2026-001
- Keywords
- Postoperative Cognitive Dysfunction, Off-Pump Coronary Artery Bypass Grafting, OPCABG, Montreal Cognitive Assessment, Prospective Cohort Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 24 May 2026 (estimated)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Off-Pump Coronary Artery Bypass Grafting Cohort | – | Procedure: Off-Pump Coronary Artery Bypass GraftingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Off-Pump Coronary Artery Bypass GraftingOff-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. | Procedure or surgery | Off-Pump Coronary Artery Bypass Grafting Cohort |
Primary outcome
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.
7 secondary outcomes
Change in Montreal Cognitive Assessment Score
Time frame: 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
Length of Postoperative Hospital Stay
Time frame: through hospital discharge, an average of 7 days
Incidence of Postoperative Complications
Time frame: through hospital discharge, an average of 7 days
Duration of Postoperative Mechanical Ventilation
Time frame: through ICU stay, an average of 3 days
Incidence of Postoperative Nausea and Vomiting
Time frame: through hospital discharge, an average of 7 days
Incidence of In-Hospital Mortality
Time frame: through hospital discharge, an average of 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy, ethical, and institutional data protection considerations.
Related trials for Postoperative Cognitive Dysfunction (POCD)
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Not yet recruitingObservational study
PCO₂ Gap and Lactate as Predictors of POCD After Cardiac Surgery
Postoperative Cognitive Dysfunction (POCD), Cardiac Surgery
Not yet recruitingObservational study
Cerebral Oximetry During Awake Carotid Endarterectomy
Carotid Stenosis, Carotid Artery Diseases
RecruitingObservational study
Early Cognitive Changes After Same-day Discharge Hip and Knee Arthroplasty
Postoperative Cognitive Dysfunction (POCD), Cognitive Change
RecruitingObservational study
The Effects of Anesthesia on Postoperative Cognitive Functions in Patients Undergoing Sleeve Gastrectomy
POCD - Postoperative Cognitive Dysfunction, Recovery Time
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wenjun Liu, PhD principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction (POCD), run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjun Liu, PhD (+86 13811258408, lwjchina@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Cognitive Dysfunction (time frame: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.