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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05848934
Other study ID # 82071993-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date December 31, 2025

Study information

Verified date April 2023
Source Nanjing University of Traditional Chinese Medicine
Contact Nengrui Guo
Phone 0086-17635599999
Email 657040251@qq.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to elucidate the imaging mechanisms of cognitive function changes in patients with coronary heart disease before and after surgery or conservative treatment, and to evaluate and predict the postoperative neurological function recovery and cerebrovascular health level of patients by combining serum markers and patient cardiovascular health evaluation indicators.


Description:

The focus of this study is to elucidate the impact of coronary heart disease on the morphology and cognitive changes of cerebral blood vessels in patients. Record imaging data, neuropsychological cognitive scales, serum markers, adverse cardiac events, and patient evaluation indicators before and after clinical treatment and follow-up period, and explore relevant factors affecting changes in cerebrovascular morphology and cognitive function.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - Confirmed coronary heart disease or risk of coronary heart disease through clinical testing - Conscious and capable of completing neuropsychological scales Exclusion Criteria: - Patients with other serious heart diseases (such as aortic aneurysm) - People with uncontrolled hypertension or diabetes - There are contraindications to MRI examination (there are metal implants in the body, such as cardiac pacemakers, metal dentures, artificial joints, non paramagnetism stents, etc.; there is claustrophobia) - Have a history of severe stroke, epilepsy, traumatic brain injury, and transient ischemic events - Existence of neurological and mental disorders (schizophrenia, depression, etc.), post-traumatic stress disorder, obsessive-compulsive disorder, multiple sclerosis, amyotrophic lateral sclerosis, etc - Have a history of alcohol or drug abuse - Those with significant organ dysfunction such as lung, liver, and kidney; - Patients with tumor, infectious diseases, blood system disease and immune system disease; - Currently participating in other clinical studies at the same time.

Study Design


Intervention

Device:
magnetic resonance image
Imaging data were collected in a strong magnetic field
Diagnostic Test:
Neuropsychological scale
Multi dimensional neuropsychological test

Locations

Country Name City State
China Yuncheng First Hospital Yuncheng Shanxi

Sponsors (3)

Lead Sponsor Collaborator
Nanjing University of Traditional Chinese Medicine Health Science Center of Xi'an Jiaotong University, Yuncheng First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of brain volume before and after treatment The change of brain volume (mm3) are evaluated by structural 3DT1 weighted MRI. Freesurfer software is used to get the measured value of the volume. before operation; 3-10 Days after operation; 1 month; 6-12months
Primary Change of cerebrovascular morphology before and after treatment The change of Cerebral vessel density, caliber and tortuosity, brain white matter hyperintensity lesion count before operation; 3-10 Days after operation; 1 month; 6-12months
Primary Change of brain function connectivity before and after operation The change of brain functional connectivity intensity are evaluated by rest stage functional MRI. DPABI software based on MATLAB is used to get the measured the matrix value of functional connectivity. before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Change of serum marker concentration before and after operation The change of serum marker concentration is evaluated by inflammatory cytokine. before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Change of plasma marker concentration before and after operation The change of plasma marker concentration is evaluated by neurofilament light chain(NFL) protein extracted from plasma. before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Change of cardiovascular risk factors before and after operation The change of cardiovascular risk factors is evaluated by blood routine and patients' living habits before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Change of executive functions before and after operation evaluated by Trail-Making Test Part A The change of executive functions are first evaluated by Trail-Making Test Part A test. The minimum value is 0 , and the maximum value is 30. This test has no clear maximum and minimum values. If the test completion time exceeds 79 seconds, it means the outcome is abnormal. The higher scores mean a worse outcome. before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Change of working memory before and after operation evaluated by Forward Digit Span The change of working memory is first evaluated by Forward Digit Span. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 7.75±1.47. The higher scores mean a better outcome. before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Change of working memory before and after operation evaluated by Backward Digit Span The change of working memory is second evaluated by Backward Digit Span. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 5.36±1.91. The higher scores mean a better outcome. before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Change of executive functions before and after operation evaluated by Trail-Making Test Part B The change of executive functions are first evaluated by Trail-Making Test Part B test. The minimum value is 0 , and the maximum value is 30. This test has no clear maximum and minimum values. If the test completion time exceeds 79 seconds, it means the outcome is abnormal. The higher scores mean a worse outcome.It is a supplement to Trail-Making Test Part A, which is optional for patients who are not familiar with the English alphabetical order before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Change of executive functions before and after operation evaluated by Digit Symbol Coding score The change of executive functions are second evaluated by Digit Symbol Coding score. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 56.53 ± 20.17. The higher scores mean a better outcome. before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary Change of episodic memory functions before and after operation evaluated by Auditory Verbal Learning test The change of episodic memory are evaluated by Auditory Verbal Learning test(AVLT-H). before operation; 3-10 Days after operation; 1 month; 6-12months
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