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

• Conditions: MRI, Functional; Carotid Artery Stenosis

• Registration Number: NCT05292729
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-01
• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-23
• Last Update Posted: 2022-03-23
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Digit Symbol Test	3 months after CAS	use to assess the cognition after CAS
Trail Making Test A/B	3 months after CAS	use to assess the cognition after CAS
digital span test	3 months after CAS	use to assess the cognition after CAS

Trial Locations

Locations (1)

the first affiliated hospital of Zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China