Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

April 16, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Through prospective registration and follow-up, this study will collect data of patients with intracranial/carotid stenosis, including clinical information, neuropsychological scales, multimodal magnetic resonance images. The investigators aim to analyze clinical and imaging characteristics of patients with cognitive impairment related to intracranial/carotid stenosis, in order to achieve early identification of cognitive impairment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • HangZhou, Zhejiang, China, 310009
        • Recruiting
        • Second Affilated Hospital of Zhejiang University, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with intracranial / carotid stenosis aged ≥ 40 years

Description

Inclusion Criteria:

  • Patients aged ≥ 40 years
  • ≥ 50% stenosis in unilateral intracranial / carotid artery
  • Written informed consent available

Exclusion Criteria:

  • Previous history of major head trauma and any intracranial surgery
  • Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
  • Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
  • Severe loss of vision, hearing, or communicative ability

Exit Criteria:

  • Not meet the inclusion criteria
  • For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
  • Any adverse or serious adverse events during the study period judged by investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the scores of Mini-mental State Examination
Time Frame: 2 years
Total score of 30. Higher scores mean a better outcome.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of stroke event including ischemic and hemorrhagic stroke
Time Frame: 2 years
2 years
Changes in cerebral glymphatic function
Time Frame: 2 years
assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
2 years
Changes in the scores of Montreal Cognitive Assessment
Time Frame: 2 years
Total score of 30
2 years
Changes in cerebral blood flow in the territory of the culprit artery
Time Frame: 2 years
2 years
Changes in the scores of Colour Trail Test
Time Frame: 2 years
2 years
Changes in the scores of Hopkins Verbal Learning Test
Time Frame: 2 years
2 years
Changes in the scores of clock drawing test
Time Frame: 2 years
2 years
Changes in the scores of Animal Fluency Test
Time Frame: 2 years
2 years
Changes in the scores of Olfactory stick test
Time Frame: 2 years
2 years
Changes in metabonomics
Time Frame: 2 years
include blood and fecal samples
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2027

Study Completion (Anticipated)

December 31, 2029

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 10, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROSE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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