Postoperative Cognitive Dysfunction (POCD)NCT07483047
Prediction Model for Postoperative Cognitive Dysfunction in Elderly Cardiac Patients: A Special Disease Cohort Study
An observational study of Postoperative Cognitive Dysfunction (POCD) and Cardiac Diseases Requiring Surgery, run by Shanghai Geriatric Medical Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction (POCD), Cardiac Diseases Requiring Surgery
- How many people
- 634 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2026to Sep 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Geriatric Medical Center
Shanghai
Shanghai Geriatric Medical Center, 02164175590, drfanghao@163.com
About this study
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.
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Cardiac Surgery Patients Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Cognitive Dysfunction Incidence in Elderly Cardiac Surgery Patients
Measured: 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start3 Mar 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive Dysfunction (POCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 634 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Geriatric Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Zhang, Shanghai Geriatric Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483047
- Sponsor's protocol ID
- B2025-055(2)
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model for Postoperative Cognitive Dysfunction in Elderly Cardiac Patients: A Special Disease Cohort Study
- ClinicalTrials.gov ID
- NCT07483047
- Acronym / sponsor ID
- B2025-055(2)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 634 participants (estimated)
- Lead sponsor
- Shanghai Geriatric Medical CenterUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Cardiac Surgery Patients Cohort | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Cognitive Dysfunction Incidence in Elderly Cardiac Surgery Patients
Time frame: 7 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction (POCD) and Cardiac Diseases Requiring Surgery, run by Shanghai Geriatric Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Fang (02164175590, drfanghao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Cognitive Dysfunction Incidence in Elderly Cardiac Surgery Patients (time frame: 7 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.