Clinical trial NCT05292729: Cognitive Function and Brain Connectivity in CAS Patients:a Rs-fMRI Study
Official title: Cognitive Function and Brain Connectivity in Carotid Artery Stenting Patients:a Rs-fMRI Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MRI, Functional
Carotid Artery Stenosis
Keywords: resting state
MRI
carotid artery stenting
cognition
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive enrolled patients with carotid artery stenosis who undergoing carotid artery stenting

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.

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)

Primary outcomes:
measure: Montreal Cognitive Assessment, MOCA
timeFrame: before CAS(within 1 week)
measure: Mini-mental State Examination，MMSE
timeFrame: before CAS(within 1 week)
measure: Montreal Cognitive Assessment, MOCA
timeFrame: 3 months after CAS
measure: Mini-mental State Examination，MMSE
timeFrame: 3 months after CAS
Secondary outcomes:
measure: Digit Symbol Test
timeFrame: before CAS(within 1 week)
measure: Digit Symbol Test
timeFrame: 3 months after CAS
measure: Trail Making Test A/B
timeFrame: before CAS(within 1 week)
measure: Trail Making Test A/B
timeFrame: 3 months after CAS
measure: digital span test
timeFrame: before CAS(within 1 week)
measure: digital span test
timeFrame: 3 months after CAS
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the first affiliated hospital of Zhejiang university
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Benyan Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References: