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Not yet recruiting NCT07093515

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

Observational Cerebral Small Vessel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Cerebral Small Vessel Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other No intervention
    No intervention

Primary outcome measures

  • Cognitive function [Time frame: Follow-up assessments will be conducted at the 2nd year and 4th year]
Secondary outcome measures (1)
  • Stroke [Time frame: Follow-up assessments will be conducted at the 2nd year and 4th year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07093515 · BRAIN-CSVD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗