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

NCT04651998 | Unknown

• 1 other identifier: CAS-fNIRS
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Parameter of evoked cerebral blood oxygenation

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

• Parameter of evoked cerebral blood oxygenation

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

• Parameter of evoked cerebral blood oxygenation

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

Interventions

MMSE, MoCA, functional near-infrared spectroscopy DIAGNOSTIC_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 Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• years old
• Severe carotid stenosis (MRA or CTA confirmed stenosis rate of 70% - 99%, NASCET standard)
• Asymptomatic or mild stroke (NIHSS ≤ 3) or TIA
• Agree to participate in the clinical trial and sign the informed consent

You may not qualify if:

• Severe stenosis or occlusion of vertebrobasilar artery and other intracranial arteries (70% - 99%)
• Left ventricular ejection fraction \< 50% or heart failure
• Other types of dementia have been diagnosed
• Severe depression, mental illness, epilepsy
• Not cooperating with cognitive task evaluation

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead
• Minhang Hospital, Fudan University: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• RenJi Hospital: collaborator
• ShuGuang Hospital: collaborator

Study Sites (1)

Shanghai 6th People's Hospital

Shanghai, 200023, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yueqi Zhu, PhD

  Shanghai Jiao Tong University Affiliated Sixth People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiangshan Deng, PhD

CONTACT

862164369181; johnson120@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 3, 2020
• Study Start: May 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 29, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)