Clinical trial NCT05848921: Evaluation of Brain Health and Surgical Efficacy in Patients With Carotid Artery Stenosis
Official title: Research on Changes of Cerebral Vascular Morphology and Cognitive Function in Patients With Carotid Artery Stenosis Before and After Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Carotid Artery Stenosis
Image
Keywords: Carotid Artery Stenosis
MRI Imaging
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Xi'an Jiaotong University
name: The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
First posted: 2023-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of brain volume before and after treatment
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months]
measure: Change of cerebrovascular morphology before and after treatment
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of brain function connectivity before and after operation
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
Secondary outcomes:
measure: Change of serum marker concentration before and after operation
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of plasma marker concentration before and after operation
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Brain evaluate basic cognition before operation
timeFrame: before operation
measure: Change of executive functions before and after operation evaluated by Trail-Making Test Part A
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of executive functions before and after operation evaluated by Digit Symbol Coding score
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of working memory before and after operation evaluated by Forward Digit Span
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of working memory before and after operation evaluated by Backward Digit Span
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of language function before and after operation evaluated by Language Fluency test
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of executive functions before and after operation evaluated by Clock Drawing Test
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
measure: Change of executive functions before and after operation evaluated by Trail-Making Test Part B
timeFrame: before operation; 3-10 Days after operation; 1 month; 6-12months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
state: Zhejiang
Study officials:
affiliation: The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
name: Bo Yin, phD
role: PRINCIPAL_INVESTIGATOR
References: