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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05848921
Other study ID # 82071993-2
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 Bo Yin, phD
Phone 0086-13857773745
Email 76yinbo@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to explore the relationship between the recovery of cerebrovascular morphology and cognitive function before and after surgical treatment in patients with carotid artery stenosis and their preoperative cardiac health status. And combined with preoperative cognitive status, serum markers, and cardiovascular health evaluation indicators, evaluate and predict the possibility of postoperative neurodegenerative diseases and the level of cerebrovascular health in patients.


Description:

The aim of this study is to evaluate the brain health status and surgical efficacy of patients with carotid artery stenosis. Firstly, investigate whether hemodynamic parameters such as blood flow reserve fraction at the carotid artery stenosis site are correlated with white matter hyperintensities and cerebral vascular morphological changes in elderly patients with normal cognition and mild cognitive impairment; Then, when the blood flow of carotid artery has been improved after surgery, compare the cerebrovascular health of patients before surgery and the way of cerebral vascular reconstruction; Combined with the postoperative neuropsychological cognitive test to explore the postoperative cognitive recovery of patients, and combined with the postoperative imaging data and the biomarker in the blood of patients at various stages, to explore the way of cerebral vascular reconstruction and changes in brain structure and function of different groups of patients behind cognitive changes.


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 50 Years to 80 Years
Eligibility Inclusion Criteria: - Aged over 50 years old; - Conscious and capable of completing neuropsychological scales - Clinical detection of carotid artery stenosis requires surgical treatment; - Compliant with carotid artery stenting or carotid endarterectomy surgical standards - Individuals with normal cognition and mild cognitive impairment Exclusion Criteria: - Degree of vascular blockage in other intracranial segments = 50% - Have a history of mental illness, nervous system disease (such as stroke) or brain injury with loss of consciousness for more than five minutes; - Neurological and psychiatric disorders unrelated to AD (schizophrenia, depression, etc.), post-traumatic stress disorder, obsessive-compulsive disorder, multiple sclerosis, amyotrophic lateral sclerosis) - Have a history of alcohol or drug abuse - There are contraindications for magnetic resonance imaging examination - Those with significant organ dysfunction such as lung, liver, and kidney; - Patients with intracranial tumors, infectious diseases, and blood system diseases; - 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 The 2rd School of Medicine,WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU Wenzhou Zhejiang

Sponsors (3)

Lead Sponsor Collaborator
Nanjing University of Traditional Chinese Medicine Health Science Center of Xi'an Jiaotong University, The 2rd School of Medicine,WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU

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 Brain evaluate basic cognition before operation Basic cognition is evaluated by Mini-mental State Examination (MMSE) and Clinical Dementia Rating (CDR) . For MMSE , The minimum value is 0 , and the maximum value is 30. The higher scores mean a better outcome. For CDR , the results are represented by scores of 0,0.5,1,2,3, and the degree of cognitive impairment is classified as normal, suspicious, mild, moderate, and severe before operation
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 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 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 language function before and after operation evaluated by Language Fluency test The change of language function is evaluated by Language Fluency test. The minimum value is 0 , and the maximum value is not clear. The normal range of results is 19.43±4.81. 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 Clock Drawing Test The change of executive functions is evaluated by Backward Digit Span. The minimum value is 0 , the maximum value is 4. 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
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