Biomarkers, Risk Assessment, Imaging, and Neurodegeneration in Cerebral Small Vessel Disease (BRAIN-CSVD)

NCT ID: NCT07093515

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2032-12-30

Brief Summary

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The BRAIN-CSVD study is a single-center prospective cohort study focusing on cerebral small vessel disease (CSVD).Patients enrolled in this research will undergo assessments for vascular risk factors, cognitive and other neurological functions, neuroimaging, and biomarkers. The study aims to explore imaging and biomarker predictors of CSVD progression, and the pathophysiological mechanisms of CSVD.

Detailed Description

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Cerebral small vessel disease (CSVD) is a common imaging finding in elderly population and can impair cognitive and other neurological functions. Radiologically, CSVD may manifest as white matter hyperintensities, lacunes, cerebral microbleeds, enlarged perivascular spaces and so on. Due to its complex imaging presentations and diverse neurological impacts, current preventive and therapeutic options for CSVD remain limited. This study involves collecting vascular risk factors, assessing global cognitive function, gait, and other neurological functions, performing multimodal MRI scans, and collecting blood samples from CSVD patients. The goal is to identify imaging markers and biomarkers that predict disease progression and to investigate the underlying pathophysiological mechanisms.

Conditions

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Cerebral Small Vessel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with cerebral small vessel disease

Patients with at least one following imaging finding: white matter hyperintensities (Fazekas \>or=1), lacune, cerebral microbleeds, recent small subcortical infarcts, or enlarged perivascular spaces (Grade 2 or more).

No intervention

Intervention Type OTHER

No intervention

Patients without cerebral small vessel disease

Patients without any following imaging finding: white matter hyperintensities (Fazekas \>or=1), lacune, cerebral microbleeds, recent small subcortical infarcts, or enlarged perivascular spaces (Grade 2 or more).

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18 years old;
* Cerebral small vessel disease on MR imaging.

Exclusion Criteria

* Cerebral infarction (except lacunar infarcts), cerebral hemorrhage, brain tumors, epilepsy, severe traumatic brain injury, or prior brain surgery;
* Secondary white matter hyperintensities due to inflammatory, toxic causes and so on;
* Contraindications to MRI.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Junjun Wang

Senior Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Junjun Wang

Role: CONTACT

8613777848063

Other Identifiers

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BRAIN-CSVD

Identifier Type: -

Identifier Source: org_study_id

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