Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease

February 7, 2023 updated by: Jinhao Lyu, Chinese PLA General Hospital
The present study aims at verifying the mutual effects between intracranial large artery atherosclerosis and cerebral small vessel disease on disease progression and prognosis by magnetic resonance imaging, and providing biomarkers for the early prevention and treatment of cerebrovascular disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cerebrovascular disease is the most common cause of death worldwide. There is a close link in structure and function between the intracranial large arteries and cerebral small vessels. Moreover, growing evidences have demonstrated that large artery atherosclerosis often coexists with small vessel disease, which may deteriorate the clinical outcomes of stroke and dementia. The mutual feedback mechanism between them is not fully understood. The present study focuses on the mechanism of mutual feedback between large artery atherosclerosis and cerebral small vessel disease by using magnetic resonance imaging. The study may provide biomarkers for the early prevention and treatment of cerebrovascular disease.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital

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

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with at least on intracranial artery ≥ 50% atherosclerotic stenosis.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • At least one intracranial artery ≥ 50% atherosclerotic stenosis
  • Modified Rankin Scale < 2
  • Mini-mental State Examination > 24

Exclusion Criteria:

  • Concurrent ipsilateral extracranial artery ≥ 50% stenosis
  • Pregnant women
  • Contraindications to magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intracranial atherosclerosis and small vessel disease
Patients diagnosed with intracranial large artery atherosclerosis and cerebral small vessel disease based on imaging screening.
Diagnostic test: Magnetic resonance imaging
Imaging diagnostics mainly based on Magnetic resonance imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression in total cerebral small vessel disease burden
Time Frame: 1-3 YEARS
Total cerebral small vessel disease burden is assessed according to a sum of scores of white matter hyperintensity, cerebral microbleeds, lacunes and enlarged perivasular spaces on magnetic resonance imaging sequences.
1-3 YEARS
Frequency of stroke recurrence
Time Frame: 1-3 YEARS
The percentage of symptomatic participants who suffer from stroke recurrence after enrollment in the territory of the targeted stenotic vessel.
1-3 YEARS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of stroke of asymptomatic participants
Time Frame: 1-3 YEARS
The percentage of asymptomatic participants who suffer from stroke after enrollment in the territory of the targeted stenotic vessel.
1-3 YEARS

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

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, 2023

Primary Completion (ANTICIPATED)

December 31, 2027

Study Completion (ANTICIPATED)

December 31, 2027

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 28, 2022

First Posted (ACTUAL)

January 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301Brainmax

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

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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