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

Carotid Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292729
• Other study ID #: 3.0T rs-fMRI
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2021
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Renjie Ji, Master
• Phone: +86 13738101002
• Email: zjujirenjie[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis
• MRI, Functional

Locations

Country	Name	City	State
China	the first affiliated hospital of Zhejiang university	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment, MOCA	use MOCA to assess the cognition before CAS	before CAS(within 1 week)
Primary	Mini-mental State Examination,MMSE	use MMSE to assess the cognition before CAS	before CAS(within 1 week)
Primary	Montreal Cognitive Assessment, MOCA	use MOCA to assess the cognition after CAS	3 months after CAS
Primary	Mini-mental State Examination,MMSE	use MMSE to assess the cognition after CAS	3 months after CAS
Secondary	Digit Symbol Test	use to assess the cognition before CAS	before CAS(within 1 week)
Secondary	Digit Symbol Test	use to assess the cognition after CAS	3 months after CAS
Secondary	Trail Making Test A/B	use to assess the cognition before CAS	before CAS(within 1 week)
Secondary	Trail Making Test A/B	use to assess the cognition after CAS	3 months after CAS
Secondary	digital span test	use to assess the cognition before CAS	before CAS(within 1 week)
Secondary	digital span test	use to assess the cognition after CAS	3 months after CAS