Evaluation of Brain Health and Surgical Efficacy in Patients With Carotid Artery Stenosis
Research on Changes of Cerebral Vascular Morphology and Cognitive Function in Patients With Carotid Artery Stenosis Before and After Surgery
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 8, 2023
April 1, 2023
2.7 years
April 28, 2023
April 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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]
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
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 Outcomes (10)
Change of serum marker concentration before and after operation
before operation; 3-10 Days after operation; 1 month; 6-12months
Change of plasma marker concentration before and after operation
before operation; 3-10 Days after operation; 1 month; 6-12months
Brain evaluate basic cognition before operation
before operation
Change of executive functions before and after operation evaluated by Trail-Making Test Part A
before operation; 3-10 Days after operation; 1 month; 6-12months
Change of executive functions before and after operation evaluated by Digit Symbol Coding score
before operation; 3-10 Days after operation; 1 month; 6-12months
- +5 more secondary outcomes
Study Arms (3)
CAS-CN
Carotid Artery Stenosis with cognitive normality
CAS-MCI
Carotid Artery Stenosis with mild cognitive impairment
HC
Healthy controls
Interventions
Eligibility Criteria
All of the patients of carotid artery stenosis group are in-patients and out-patients in the cardiac surgery department from the research center. The subjects of control group are recruited from community.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Yin, phD
The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investgator
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 8, 2023
Study Start
May 1, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 8, 2023
Record last verified: 2023-04