Cognitive Function and Brain Connectivity in CAS Patients:a Rs-fMRI Study

Sponsor

First Affiliated Hospital of Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05292729

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
MRI, Functional Carotid Artery Stenosis

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Outcome Measures

Primary Outcome Measures

Montreal Cognitive Assessment, MOCA [before CAS(within 1 week)]
use MOCA to assess the cognition before CAS
Mini-mental State Examination，MMSE [before CAS(within 1 week)]
use MMSE to assess the cognition before CAS
Montreal Cognitive Assessment, MOCA [3 months after CAS]
use MOCA to assess the cognition after CAS
Mini-mental State Examination，MMSE [3 months after CAS]
use MMSE to assess the cognition after CAS

Secondary Outcome Measures

Digit Symbol Test [before CAS(within 1 week)]
use to assess the cognition before CAS
Digit Symbol Test [3 months after CAS]
use to assess the cognition after CAS
Trail Making Test A/B [before CAS(within 1 week)]
use to assess the cognition before CAS
Trail Making Test A/B [3 months after CAS]
use to assess the cognition after CAS
digital span test [before CAS(within 1 week)]
use to assess the cognition before CAS
digital span test [3 months after CAS]
use to assess the cognition after CAS

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the first affiliated hospital of Zhejiang university	Hangzhou	Zhejiang	China	310016

Sponsors and Collaborators

First Affiliated Hospital of Zhejiang University

Investigators

Principal Investigator: Benyan Luo, PhD, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital of Zhejiang University

ClinicalTrials.gov Identifier:

NCT05292729

Other Study ID Numbers:

3.0T rs-fMRI

First Posted:

Mar 23, 2022

Last Update Posted:

Mar 23, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by First Affiliated Hospital of Zhejiang University

resting state

MRI

carotid artery stenting

cognition

Additional relevant MeSH terms:

Carotid Stenosis

Study Results

No Results Posted as of Mar 23, 2022