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Clinical Trials/NCT05292729
NCT05292729
Unknown
Not Applicable

Cognitive Function and Brain Connectivity in Carotid Artery Stenting Patients:a Rs-fMRI Study

First Affiliated Hospital of Zhejiang University1 site in 1 country30 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
MRI, Functional
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
30
Locations
1
Primary Endpoint
Montreal Cognitive Assessment, MOCA
Last Updated
4 years ago

Overview

Brief Summary

This is a prospective study aimed to explore the changes of cognitive function after surgery for CAS and the correlation with brain connectivity, in order to look for the clinical biomarkers to predict the carotid stent implantation for patients which can effect the cognition

Detailed Description

Carotid artery stenting (CAS) can significantly decrease the incidence of ischemic stroke in patients with severe carotid artery stenosis has been confirmed in large randomized controlled studies (1, 2).Previous studies showed carotid artery stenosis is closely related to cognitive dysfunction, including asymptomatic carotid artery stenosis(≥70%).Cognitive impairment is one of the most serious problem facing the elderly. The impact on cognitive function in patients with CAS has been discussed by many researchers, however the effect still remained conflicting. In past few years, several imaging techniques, such as resting-state functional MRI (R-fMRI), had been increasingly used to study cognitive impairment in humans. In this study, we evaluated the cognition performance in severe carotid artery stenosis patients undergoing CAS and explored the mechanisms underlying the cognition changes by the Rs-fMRI. Inclusion criteria: * age between 55 years and 80 years * unilateral internal carotid artery stenotic degree ≥ 70% * right-hand-dominant * free of dementia, and depression * modified Rankin Scale: 0 or 1 * education ≥6 years * obtained written informed consent. Exclusion criteria: * contralateral internal carotid artery stenosis ≥ 50% * posterior circulation diseases * MMSE \< 26, which is a cut-off value for mild cognitive impairment * severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure) * any contraindications for MRI scan (e.g., metal implants) * Non atherosclerotic stenosis, such as dissection, vasculitis.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
July 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age between 55 years and 80 years
  • unilateral internal carotid artery stenotic degree ≥ 70%
  • right-hand-dominant
  • free of stroke, TIA, dementia, and depression
  • modified Rankin Scale: 0 or 1
  • education ≥6 years
  • obtained written informed consent.

Exclusion Criteria

  • contralateral internal carotid artery stenosis ≥ 50%
  • posterior circulation diseases
  • MMSE \< 26, which is a cut-off value for mild cognitive impairment
  • severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure and history of stroke)
  • any contraindications for MRI scan (e.g., metal implants)

Outcomes

Primary Outcomes

Montreal Cognitive Assessment, MOCA

Time Frame: 3 months after CAS

use MOCA to assess the cognition after CAS

Mini-mental State Examination,MMSE

Time Frame: 3 months after CAS

use MMSE to assess the cognition after CAS

Secondary Outcomes

  • Digit Symbol Test(3 months after CAS)
  • Trail Making Test A/B(3 months after CAS)
  • digital span test(3 months after CAS)

Study Sites (1)

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