Predicting thinking and memory problems after heart surgery in older adults
Official title: Prediction Model for Postoperative Cognitive Dysfunction in Elderly Cardiac Patients: A Special Disease Cohort Study
Run by Shanghai Geriatric Medical Center · NCT07483047 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 634 (estimated) |
| Sponsor | Shanghai Geriatric Medical Center Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | March 3, 2026 |
| Main results expected | September 2028 |
| Study ends | September 2028 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07483047 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous research has shown associations between some blood markers or neuroimaging changes and postoperative cognitive problems, but robust, widely validated prediction models remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Shanghai Geriatric Medical Center
Shanghai, China Recruiting
Study contacts
- Study coordinator: Hao Fang
- Email: drfanghao@163.com
- Phone: 02164175590
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.