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Recruiting NCT07483047

NCT07483047 Prediction Model for Postoperative Cognitive Dysfunction in Elderly Cardiac Patients: A Special Disease Cohort Study

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Clinical Trial Summary
NCT ID NCT07483047
Status Recruiting
Phase
Sponsor Shanghai Geriatric Medical Center
Condition Postoperative Cognitive Dysfunction (POCD)
Study Type OBSERVATIONAL
Enrollment 634 participants
Start Date 2026-03-03
Primary Completion 2028-09

Trial Parameters

Condition Postoperative Cognitive Dysfunction (POCD)
Sponsor Shanghai Geriatric Medical Center
Study Type OBSERVATIONAL
Phase N/A
Enrollment 634
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2026-03-03
Completion 2028-09

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Brief Summary

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.

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 on

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