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Research on the Relationship Between Cognitive Function Changes and Cerebrovascular Health in Patients With Coronary Heart Disease

Evaluation and Prognosis of Cerebrovascular and Neurological Health Status in Patients With Coronary Heart Disease After Treatment

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05848934
Enrollment
100
Registered
2023-05-08
Start date
2023-05-01
Completion date
2025-12-31
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease, Image

Keywords

Coronary Heart Disease, MRI Imaging, Neuropsychological assessment

Brief 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.

Detailed 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.

Interventions

Imaging data were collected in a strong magnetic field

Multi dimensional neuropsychological test

Sponsors

Xi'an Jiaotong University
CollaboratorOTHER
Yuncheng First Hospital
CollaboratorUNKNOWN
Nanjing University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of brain volume before and after treatmentbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe change of brain volume (mm3) are evaluated by structural 3DT1 weighted MRI. Freesurfer software is used to get the measured value of the volume.
Change of cerebrovascular morphology before and after treatmentbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe change of Cerebral vessel density, caliber and tortuosity, brain white matter hyperintensity lesion count
Change of brain function connectivity before and after operationbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe 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.

Secondary

MeasureTime frameDescription
Change of executive functions before and after operation evaluated by Trail-Making Test Part Abefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe 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.
Change of working memory before and after operation evaluated by Forward Digit Spanbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe 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.
Change of working memory before and after operation evaluated by Backward Digit Spanbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe 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.
Change of serum marker concentration before and after operationbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe change of serum marker concentration is evaluated by inflammatory cytokine.
Change of executive functions before and after operation evaluated by Digit Symbol Coding scorebefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe 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.
Change of episodic memory functions before and after operation evaluated by Auditory Verbal Learning testbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe change of episodic memory are evaluated by Auditory Verbal Learning test(AVLT-H).
Change of executive functions before and after operation evaluated by Trail-Making Test Part Bbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe 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
Change of plasma marker concentration before and after operationbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe change of plasma marker concentration is evaluated by neurofilament light chain(NFL) protein extracted from plasma.
Change of cardiovascular risk factors before and after operationbefore operation; 3-10 Days after operation; 1 month; 6-12monthsThe change of cardiovascular risk factors is evaluated by blood routine and patients' living habits

Countries

China

Contacts

Primary ContactNengrui Guo
657040251@qq.com0086-17635599999
Backup ContactLijun Bai, phD
bailijun@xjtu.edu.cn0086-15129034948

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026