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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carotid Artery Stenosis; Image
• Intervention / Treatment: Device: magnetic resonance image; Diagnostic test: Neuropsychological scale

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Bo Yin, phD; Phone Number: 0086-13857773745; Email: 76yinbo@163.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU
      • Contact: Bo Yin, phD; Phone Number: 0086-13857773745; Email: 76yinbo@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HC; Healthy controls	Device: magnetic resonance image; Imaging data were collected in a strong magnetic field; Diagnostic test: Neuropsychological scale; Multi dimensional neuropsychological test
CAS-CN; Carotid Artery Stenosis with cognitive normality	Device: magnetic resonance image; Imaging data were collected in a strong magnetic field; Diagnostic test: Neuropsychological scale; Multi dimensional neuropsychological test
CAS-MCI; Carotid Artery Stenosis with mild cognitive impairment	Device: magnetic resonance image; Imaging data were collected in a strong magnetic field; Diagnostic test: Neuropsychological scale; Multi dimensional neuropsychological test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Nanjing University of Traditional Chinese Medicine
• Collaborators: 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
• Investigators: Principal Investigator: Bo Yin, phD, The 2rd School of Medicine，WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: MRI Imaging; Carotid Artery Stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 82071993-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No