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

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Diagnostic test: MMSE, MoCA, functional near-infrared spectroscopy

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.

• Study Type: Observational
• Enrollment (Estimated): 74

Contacts and Locations

• Study Contact: Name: Jiangshan Deng, PhD; Phone Number: 862164369181; Email: johnson120@126.com

Study Locations

• China
  • Shanghai, China, 200023
    • Recruiting
    • Shanghai 6th People's Hospital
    • Contact: Yue-Qi Zhu, Dr.; Phone Number: 0086-021-64844183; Email: zyq1111@126.com
    • Principal Investigator: Yue-Qi Zhu, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with high grade carotid artery stenosis treated with carotid artery stent from 5 hospitals.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Collaborators: RenJi Hospital; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; ShuGuang Hospital; Minhang Hospital, Fudan University
• Investigators: Principal Investigator: Yueqi Zhu, PhD, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: carotid artery stent, functional near-infrared spectroscopy, vascular cognitive impairment,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: CAS-fNIRS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No