Cerebral Small Vessel DiseaseBRAIN-CSVDNCT07093515
Biomarkers, Risk Assessment, Imaging, and Neurodegeneration in Cerebral Small Vessel Disease (BRAIN-CSVD)
An observational study of Cerebral Small Vessel Disease, run by Zhejiang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to 30 Dec 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital-based patients
Who may be able to join
- Age >= 18 years old;
- Cerebral small vessel disease on MR imaging.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Cohort Study of Biomarkers, Risk Assessment, Imaging, and Neurodegeneration in Patients With Cerebral Small Vessel Disease
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.
Read the 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.
- Conditions
- Cerebral Small Vessel Disease
- Being tested
- No intervention
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Montreal Cognitive Assessment (MoCA) score, with a range of 0 to 30 points, where higher scores indicate better cognitive function.
Measured: Follow-up assessments will be conducted at the 2nd year and 4th year
Secondary outcomes (1)
Stroke
The rate of the patients with ischemic stroke or cerebral hemorrhagic stroke
Measured: Follow-up assessments will be conducted at the 2nd year and 4th year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startOct 2025 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjun Wang, Zhejiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093515
- Sponsor's protocol ID
- BRAIN-CSVD
- Acronym
- BRAIN-CSVD
- Status last verified
- Apr 2025
- First submitted
- 21 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Biomarkers, Risk Assessment, Imaging, and Neurodegeneration in Patients With Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT07093515
- Acronym / sponsor ID
- BRAIN-CSVD / BRAIN-CSVD
- Conditions
- Cerebral Small Vessel Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zhejiang HospitalUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cerebral small vessel disease | – | Other: No interventionPatients 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). |
| Patients without cerebral small vessel disease | – | Other: No interventionPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital-based patients
Key inclusion criteria (2 listed)
- Age >= 18 years old;
- Cerebral small vessel disease on MR imaging.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients with cerebral small vessel disease, Patients without cerebral small vessel disease |
Primary outcome
Cognitive function
Time frame: Follow-up assessments will be conducted at the 2nd year and 4th year
Montreal Cognitive Assessment (MoCA) score, with a range of 0 to 30 points, where higher scores indicate better cognitive function.
1 secondary outcome
Stroke
Time frame: Follow-up assessments will be conducted at the 2nd year and 4th year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Disease, run by Zhejiang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junjun Wang (8613777848063, wjj005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: Follow-up assessments will be conducted at the 2nd year and 4th year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.