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

A Cohort Study of Biomarkers, Risk Assessment, Imaging, and Neurodegeneration in Patients With Cerebral Small Vessel Disease

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07093515
Acronym
BRAIN-CSVD
Enrollment
500
Registered
2025-07-30
Start date
2025-10-31
Completion date
2032-12-30
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Small Vessel Disease

Brief summary

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

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Zhejiang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive functionFollow-up assessments will be conducted at the 2nd year and 4th yearMontreal Cognitive Assessment (MoCA) score, with a range of 0 to 30 points, where higher scores indicate better cognitive function.

Secondary

MeasureTime frameDescription
StrokeFollow-up assessments will be conducted at the 2nd year and 4th yearThe rate of the patients with ischemic stroke or cerebral hemorrhagic stroke

Contacts

Primary ContactJunjun Wang
wjj005@163.com8613777848063

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026