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

NCT ID: NCT05292729

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-07-01

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.

Conditions

MRI, Functional; Carotid Artery Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benyan Luo, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

the first affiliated hospital of Zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Renjie Ji, Master

Role: CONTACT

zjujirenjie@zju.edu.cn

+86 13738101002

Hanfeng Chen, Master

Role: CONTACT

chf0106@foxmail.com

+86 18768115416

Facility Contacts

仁杰 计

Role: primary

13738101002

References

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.

Reference Type: DERIVED

PMID: 40302264 (View on PubMed)

Other Identifiers

3.0T rs-fMRI

Identifier Type: -

Identifier Source: org_study_id