Cognitive Function and Brain Connectivity in CAS Patients:a Rs-fMRI Study

Cognitive Function and Brain Connectivity in Carotid Artery Stenting Patients:a Rs-fMRI Study

This is a prospective study aimed to explore the changes of cognitive function after surgery for CAS and the correlation with brain connectivity, in order to look for the clinical biomarkers to predict the carotid stent implantation for patients which can effect the cognition

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Stenosis; MRI, Functional

Detailed Description

Carotid artery stenting (CAS) can significantly decrease the incidence of ischemic stroke in patients with severe carotid artery stenosis has been confirmed in large randomized controlled studies (1, 2).Previous studies showed carotid artery stenosis is closely related to cognitive dysfunction, including asymptomatic carotid artery stenosis(≥70%).Cognitive impairment is one of the most serious problem facing the elderly. The impact on cognitive function in patients with CAS has been discussed by many researchers, however the effect still remained conflicting.

In past few years, several imaging techniques, such as resting-state functional MRI (R-fMRI), had been increasingly used to study cognitive impairment in humans. In this study, we evaluated the cognition performance in severe carotid artery stenosis patients undergoing CAS and explored the mechanisms underlying the cognition changes by the Rs-fMRI.

Inclusion criteria:

• age between 55 years and 80 years
• unilateral internal carotid artery stenotic degree ≥ 70%
• right-hand-dominant
• free of dementia, and depression
• modified Rankin Scale: 0 or 1
• education ≥6 years
• obtained written informed consent.

Exclusion criteria:

• contralateral internal carotid artery stenosis ≥ 50%
• posterior circulation diseases
• MMSE < 26, which is a cut-off value for mild cognitive impairment
• severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure)
• any contraindications for MRI scan (e.g., metal implants)
• Non atherosclerotic stenosis, such as dissection, vasculitis.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Renjie Ji, Master; Phone Number: +86 13738101002; Email: zjujirenjie@zju.edu.cn
• Study Contact Backup: Name: Hanfeng Chen, Master; Phone Number: +86 18768115416; Email: chf0106@foxmail.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University
      • Principal Investigator: Benyan Luo, PhD
      • Contact: 仁杰 计; Phone Number: 13738101002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

consecutive enrolled patients with carotid artery stenosis who undergoing carotid artery stenting

Description

Inclusion Criteria:

• age between 55 years and 80 years
• unilateral internal carotid artery stenotic degree ≥ 70%
• right-hand-dominant
• free of stroke, TIA, dementia, and depression
• modified Rankin Scale: 0 or 1
• education ≥6 years
• obtained written informed consent.

Exclusion Criteria:

• contralateral internal carotid artery stenosis ≥ 50%
• posterior circulation diseases
• MMSE < 26, which is a cut-off value for mild cognitive impairment
• severe systemic diseases and neuropsychiatric diseases (such as congestive heart failure and history of stroke)
• any contraindications for MRI scan (e.g., metal implants)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment, MOCA	use MOCA to assess the cognition before CAS	before CAS(within 1 week)
Mini-mental State Examination，MMSE	use MMSE to assess the cognition before CAS	before CAS(within 1 week)
Montreal Cognitive Assessment, MOCA	use MOCA to assess the cognition after CAS	3 months after CAS
Mini-mental State Examination，MMSE	use MMSE to assess the cognition after CAS	3 months after CAS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digit Symbol Test	use to assess the cognition before CAS	before CAS(within 1 week)
Digit Symbol Test	use to assess the cognition after CAS	3 months after CAS
Trail Making Test A/B	use to assess the cognition before CAS	before CAS(within 1 week)
Trail Making Test A/B	use to assess the cognition after CAS	3 months after CAS
digital span test	use to assess the cognition before CAS	before CAS(within 1 week)
digital span test	use to assess the cognition after CAS	3 months after CAS

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Benyan Luo, PhD, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: MRI; cognition; resting state; carotid artery stenting
• 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: 3.0T rs-fMRI

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
• product manufactured in and exported from the U.S.: No