Predicting thinking and memory problems after heart surgery in older adults

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

This project will test whether blood protein markers and brain MRI scans can predict thinking and memory problems after cardiac surgery in people aged 65 and older.

Quick facts

• Study type: Observational
• Enrollment: 634 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Shanghai Geriatric Medical Center (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07483047 on ClinicalTrials.gov

What this trial studies

This is a prospective cohort of patients aged 65 and older who undergo cardiac surgery with cardiopulmonary bypass, with blood samples and functional MRI collected at baseline and key postoperative time points. Cognitive status will be measured with standard scales (MMSE and MoCA) before and after surgery. Researchers will search for peripheral blood protein biomarkers, examine relationships between fMRI features and postoperative cognitive decline, and combine these data to build an early prediction model. The goal is to use multimodal data to improve perioperative risk stratification and guide interventions to reduce postoperative cognitive dysfunction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 65 or older scheduled for cardiac surgery with cardiopulmonary bypass who have normal liver and kidney tests, no active infection, can complete MMSE/MoCA testing, and provide informed consent.

Not a fit: Patients with preexisting cognitive impairment by the study MMSE thresholds, active systemic infection, recent significant liver disease, or other conditions that interfere with study measures are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the model could allow earlier identification of patients at high risk for postoperative cognitive dysfunction so clinicians can tailor perioperative care and follow-up to reduce its incidence and severity.

How similar studies have performed: Previous research has shown associations between some blood markers or neuroimaging changes and postoperative cognitive problems, but robust, widely validated prediction models remain limited.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Shanghai Geriatric Medical Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Hao Fang

Conditions Postoperative Cognitive Dysfunction; Cardiac Diseases Requiring Surgery