NCT05292729

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 23, 2022

Status Verified

December 1, 2021

Enrollment Period

7 months

First QC Date

December 27, 2021

Last Update Submit

March 14, 2022

Conditions

Keywords

resting stateMRIcarotid artery stentingcognition

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Digit Symbol Test

    before CAS(within 1 week)

  • Digit Symbol Test

    3 months after CAS

  • Trail Making Test A/B

    before CAS(within 1 week)

  • Trail Making Test A/B

    3 months after CAS

  • digital span test

    before CAS(within 1 week)

  • +1 more secondary outcomes

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital of Zhejiang university

Hangzhou, Zhejiang, 310016, China

RECRUITING

Related Publications (1)

  • Ji R, Zhang S, Chen H, Deng C, Xu Z, Zhang J, Luo B. Impact of Endovascular Revascularization on Functional Connectivity and Cognition in Symptomatic Chronic Internal Carotid Artery Occlusion Patients: A Preliminary Exploratory Study. J Integr Neurosci. 2025 Apr 24;24(4):36330. doi: 10.31083/JIN36330.

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Benyan Luo, PhD

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanfeng Chen, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2021

First Posted

March 23, 2022

Study Start

December 1, 2021

Primary Completion

June 30, 2022

Study Completion

July 1, 2022

Last Updated

March 23, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations