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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04651998

Enrollment

Registered

2020-12-03

Start date

2021-05-01

Completion date

2024-12-30

Last updated

2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Stenosis

Keywords

carotid artery stent, functional near-infrared spectroscopy, vascular cognitive impairment,

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTMMSE, MoCA, functional near-infrared spectroscopy

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of cognitive function score	MMSE score at baseline, 6 months after revascularization. Change of the score is calculated.	Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function

Secondary

Measure	Time frame	Description
Parameter of evoked cerebral blood oxygenation	Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.	Means of HbO detected by functional near-infrared spectroscopy

Countries

China

Contacts

Primary ContactJiangshan Deng, PhD

johnson120@126.com862164369181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026