Evaluation of Brain Health and Surgical Efficacy in Patients With Carotid Artery Stenosis

Carotid Artery Stenosis Clinical Trial

Official title:

Research on Changes of Cerebral Vascular Morphology and Cognitive Function in Patients With Carotid Artery Stenosis Before and After Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05848921
• Other study ID #: 82071993-2
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic
• Image

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