Cognitive Function and Brain Connectivity in CAS Patients... | NCT05292729

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

NCT05292729

Sponsor

First Affiliated Hospital of Zhejiang University

Status

Unknown status

Last Update Posted

Mar 23, 2022Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

MRI, Functional
Carotid Artery Stenosis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Jul 1, 2022Estimated

First Submitted Date

Dec 27, 2021

First Submission Date that Met QC Criteria

Mar 14, 2022

First Posted Date

Mar 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2022

Last Update Posted Date

Mar 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Digit Symbol Test	use to assess the cognition before CAS	before CAS(within 1 week)
Digit Symbol Test	use to assess the cognition after CAS

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

consecutive enrolled patients with carotid artery stenosis who undergoing carotid artery stenting

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Renjie Ji, Master	Contact	+86 13738101002		zjujirenjie@zju.edu.cn
Hanfeng Chen, Master	Contact	+86 18768115416		chf0106@foxmail.com

Overall Officials

Name	Affiliation	Role
Benyan Luo, PhD	Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the first affiliated hospital of Zhejiang university	Recruiting	Hangzhou	Zhejiang	310016	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40302264	Derived	Ji R, Zhang S, Chen H, Deng C, Xu Z, Zhang J, Luo B. Impact of Endovascular Revascularization on Functional Connectivity and Cognition in Symptomatic Chronic Internal Carotid Artery Occlusion Patients: A Preliminary Exploratory Study. J Integr Neurosci. 2025 Apr 24;24(4):36330. doi: 10.31083/JIN36330.

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases