Prediction Model for Postoperative Cognitive Dysfunction in Elderly Cardiac Patients: A Special Disease Cohort Study

March 15, 2026 updated by: Xue Zhang, Shanghai Geriatric Medical Center
This is a prospective cohort study aiming to construct a prediction model for postoperative cognitive dysfunction (POCD) in elderly cardiac patients. We plan to enroll elderly patients aged ≥65 years undergoing cardiac surgery. Peripheral blood samples and functional magnetic resonance imaging (fMRI) data will be collected at baseline and key time points post-surgery. The primary objectives are to identify novel peripheral blood protein biomarkers for POCD, explore the correlation between fMRI characteristics and POCD, and establish a reliable early prediction model to improve perioperative management and reduce the incidence of POCD in elderly cardiac surgical patients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

634

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 Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Geriatric Medical Center
        • Contact:
          • Shanghai Geriatric Medical Center
          • Phone Number: 02164175590
          • Email: drfanghao@163.com

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is a prospective cohort study enrolling elderly patients aged ≥65 years, regardless of gender, who are scheduled for elective cardiac surgery with cardiopulmonary bypass. Eligible subjects must have normal liver and renal function, no evidence of active infection during screening, and be able to cooperate with MMSE and MoCA cognitive assessments. Patients with conditions that may interfere with study results, active liver disease, preoperative severe cognitive impairment, uncontrolled comorbidities, organ transplantation history, demyelinating diseases, or participation in other clinical trials will be excluded. All participants provide written informed consent.

Description

Inclusion Criteria:

  • Subjects aged ≥65 years, with no gender restriction. Patients meet the indications for cardiac surgery (cardiac surgery with cardiopulmonary bypass).

Normal liver and renal function during the screening period. No evidence of active infection during the screening period. Able to cooperate in answering questions related to the MMSE and MoCA cognitive scales during the screening period.

Have signed the informed consent form.

Exclusion Criteria:

  • The investigator considers that the subject has conditions that may interfere with the study results.

Subjects with evidence of active liver disease (liver function test results: ALT or AST ≥ 2 times the upper limit of normal [ULN]) or chronic active hepatitis B or C within 1 month.

Active systemic infection requiring antibacterial drugs within 1 week before surgery.

Preoperative low MMSE score (illiterate: <17 points; primary school education: <20 points; middle school education or above: <24 points).

Patients with one or more of the following diseases:

Classified as obese (body mass index ≥ 30 kg/m²); Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg); History of organ transplantation, including corneal transplantation; Any clinically significant uncontrolled respiratory disease, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, or pleural effusion; Previously diagnosed or suspected demyelinating diseases, including multiple sclerosis, Guillain-Barré syndrome, etc.; Use of any glucocorticoids or immunosuppressive agents; Any disease that significantly affects the nervous system. Participation in other clinical trials.

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
Elderly Cardiac Surgery Patients Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative Cognitive Dysfunction Incidence in Elderly Cardiac Surgery Patients
Time Frame: 7 days post-surgery
7 days post-surgery

Collaborators and Investigators

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

Sponsor

Shanghai Geriatric Medical Center

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 (Actual)

March 3, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2025-055(2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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