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

NCT07093515 | Not Yet Recruiting

• 1 other identifier: BRAIN-CSVD
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Small Vessel Disease

Outcome Measures

Primary Outcomes (1)

• Cognitive function

  Montreal Cognitive Assessment (MoCA) score, with a range of 0 to 30 points, where higher scores indicate better cognitive function.

  Follow-up assessments will be conducted at the 2nd year and 4th year

Secondary Outcomes (1)

• Stroke

  Follow-up assessments will be conducted at the 2nd year and 4th year

Study Arms (2)

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).

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).

Other: No intervention

Interventions

No intervention OTHER

No intervention

Patients with cerebral small vessel disease; Patients without cerebral small vessel disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital-based patients

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Hospital: lead

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Junjun Wang

CONTACT

8613777848063; wjj005@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2032
• Last Updated: July 30, 2025

Record last verified: 2025-04