Prediction Model for Postoperative Cognitive Dysfunction in Elderly Cardiac Patients: A Special Disease Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Postoperative Cognitive Dysfunction (POCD), Cardiac Diseases Requiring Surgery. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Postoperative Cognitive Dysfunction Incidence in Elderly Cardiac Surgery Patients [Time frame: 7 days post-surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Geriatric Medical Center — Shanghai
Identifiers
NCT: NCT07483047 · B2025-055(2)