Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning

N/AUnknownNCT04651998

Shanghai Jiao Tong University Affiliated Sixth People's Hospital74 enrolled

Overview

Cerebral hemodynamic compromise from internal carotid artery stenosis may be a cause of vascular cognitive impairment that is amenable to treatment by revascularization. The effect of carotid artery stent on evoked cerebral blood oxygenation and neurocognitive functioning will be evaluated by functional near-infrared spectroscopy. Carotid artery stent could benefit cerebral blood oxygenation after stent and improving neurocognitive functioning after 6 months.

Patients with high grade internal carotid artery stenosis intended to carotid artery stent are brought to this study. Global cognitive function and evoked cerebral blood oxygenation are evaluated before and after stent, followed up at 6 months later. Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment (MoCA) are used for the global cognitive test. Evoked cerebral blood oxygenation is evaluated using functional near-infrared spectroscopy(fNIRS) through performing mental task( N-back task, Go/no go task, and verbal fluency task ). All the patients from different centers are conducted the test at the only main center by one doctor. The parameter of fNIRS and score of cognitive test of each patient are compared before and after stent.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Carotid Artery Stenosis

Interventions

MMSE, MoCA, functional near-infrared spectroscopyDIAGNOSTIC_TEST

MMSE and MoCA are used for cognitive test before carotid artery stent implant and 6 months later. Cerebral blood oxygenation is evaluated by functional near-infrared spectroscopy under the mental task before and after revascularization within one week, 6 months later respectively.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 35-80 years old 2. Severe carotid stenosis (MRA or CTA confirmed stenosis rate of 70% - 99%, NASCET standard) 3. Asymptomatic or mild stroke (NIHSS ≤ 3) or TIA 4. Agree to participate in the clinical trial and sign the informed consent Exclusion Criteria: 1. Severe stenosis or occlusion of vertebrobasilar artery and other intracranial arteries (70% - 99%) 2. Left ventricular ejection fraction \< 50% or heart failure 3. Other types of dementia have been diagnosed 4. Severe depression, mental illness, epilepsy 5. Not cooperating with cognitive task evaluation

Locations (1)

Shanghai 6th People's Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Change of cognitive function score

Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function

Time frame: MMSE score at baseline, 6 months after revascularization. Change of the score is calculated.

Secondary Outcomes

Parameter of evoked cerebral blood oxygenation

Means of HbO detected by functional near-infrared spectroscopy

Time frame: Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.

Parameter of evoked cerebral blood oxygenation

Skewness of HbO detected by functional near-infrared spectroscopy

Time frame: Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.

Parameter of evoked cerebral blood oxygenation

kurtosis of HbO detected by functional near-infrared spectroscopy

Time frame: Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.

Central Contacts

Jiangshan Deng, PhD

CONTACT

862164369181 johnson120@126.com

Data from ClinicalTrials.gov

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