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

Carotid Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651998
• Other study ID #: CAS-fNIRS
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Contact: Jiangshan Deng, PhD
• Phone: 862164369181
• Email: johnson120[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Diagnostic Test:
• MMSE, 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.

Locations

Country	Name	City	State
China	Shanghai 6th People's Hospital	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Minhang Hospital, Fudan University, RenJi Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, ShuGuang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cognitive function score	Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function	MMSE score at baseline, 6 months after revascularization. Change of the score is calculated.
Secondary	Parameter of evoked cerebral blood oxygenation	Means of HbO detected by functional near-infrared spectroscopy	Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.
Secondary	Parameter of evoked cerebral blood oxygenation	Skewness of HbO detected by functional near-infrared spectroscopy	Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.
Secondary	Parameter of evoked cerebral blood oxygenation	kurtosis of HbO detected by functional near-infrared spectroscopy	Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.