Cerebral Small Vessel DiseasesNCT04318119
Cerebral Small Vessel Disease Registry Study
An observational study of Cerebral Small Vessel Diseases, run by Bin Cai at 1 site in China.
Trial summary
The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Small Vessel Disease (CSVD) and in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CSVD, , to find independent imaging markers, and to optimize clinical management. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cerebral Small Vessel Diseases
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2019to 18 Nov 2055
- How long will I take part?
- 30 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who are diagnosed as Cerebral Small Vessel Disease
Who may be able to join
- Sign informed consent.
- Age>18
- At least one of the following CSVD MRI characteristics: ①recent small subcortical infarct;②lacune of presumed vascular origin;③white matter hypertensity of presumed vascular origin;④perivascular space;⑤cerebral microbleeds;⑥brain atrophy
Who cannot join
- Unable to cooperate with inspectors
- Non-vascular white matter lesions
- Other cognitive diseases (such as alzheimer's disease, Parkinson's disease or thyroid disease)
- Serious systemic illness, such as heart, liver, kidney disease or major mental illness
- Contraindications for imaging examination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology , First Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, 350004
Cai Bin, 13338413842 ext. 86, caibin929@163.com
About this study
The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Small Vessel Disease (CSVD) and in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CSVD, , to find independent imaging markers, and to optimize clinical management.
- Conditions
- Cerebral Small Vessel Diseases
- Medical subject headings
- Cerebral Small Vessel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall outcomes in patients with cerebral small vessel disease.
record the occurrence of stroke and use modified Rankin Scale (mRS) to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Measured: From date of enrollment until the date of death from any cause, assessed up to 30 years
Secondary outcomes (4)
the development of the burden of microbleeds in MRI
using MARS scale to evaluate the development of the burden of microbleeds
Measured: From date of enrollment until the date of death from any cause, assessed up to 30 years
the development of the burden of white matter hypertension in MRI
using Fazakes scale to evaluate the development of the burden of white matter hypertension
Measured: From date of enrollment until the date of death from any cause, assessed up to 30 years
the development of lacunes in MRI
record the number and location of lacunes
Measured: From date of enrollment until the date of death from any cause, assessed up to 30 years
the development of enlarged perivascular space in MRI
record the number and location of enlarged perivascular space
Measured: From date of enrollment until the date of death from any cause, assessed up to 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start18 Nov 2019
- Primary completion18 Nov 2049 (estimated)
- Study completion18 Nov 2055 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel DiseasesStudies 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
- 3,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Bin Cai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin Cai, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318119
- Sponsor's protocol ID
- MRCTA,ECFAH of FMU [2019]245
- Status last verified
- Sep 2023
- First submitted
- 14 Mar 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu F, Xie W, Fan M, Wang Y, Xu S, Qiu W, Yang T, Lv H, Huang H, Wu Y, Fu Y, Cai B. Intracerebral Hemorrhage in Autosomal Dominant Cerebral Arteriopathy With Subcortical Infarcts and Leukoencephalopathy. Eur J Neurol. 2025 Mar;32(3):e70100. doi: 10.1111/ene.70100.
PubMed 40067051
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Small Vessel Disease Registry Study
- ClinicalTrials.gov ID
- NCT04318119
- Acronym / sponsor ID
- MRCTA,ECFAH of FMU [2019]245
- Conditions
- Cerebral Small Vessel Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Bin CaiUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 18 Nov 2049 (estimated)
- Study completion
- 18 Nov 2055 (estimated)
- First posted
- 23 Mar 2020 (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 aim of this study is to determine the clinical spectrum and natural progression of Cerebral Small Vessel Disease (CSVD) and in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CSVD, , to find independent imaging markers, and to optimize clinical management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who are diagnosed as Cerebral Small Vessel Disease
Key inclusion criteria (3 listed)
- Sign informed consent.
- Age>18
- At least one of the following CSVD MRI characteristics: ①recent small subcortical infarct;②lacune of presumed vascular origin;③white matter hypertensity of presumed vascular origin;④perivascular space;⑤cerebral microbleeds;⑥brain atrophy
Key exclusion criteria (5 listed)
- Unable to cooperate with inspectors
- Non-vascular white matter lesions
- Other cognitive diseases (such as alzheimer's disease, Parkinson's disease or thyroid disease)
- Serious systemic illness, such as heart, liver, kidney disease or major mental illness
- Contraindications for imaging examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall outcomes in patients with cerebral small vessel disease.
Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years
record the occurrence of stroke and use modified Rankin Scale (mRS) to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
4 secondary outcomes
the development of the burden of microbleeds in MRI
Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years
the development of the burden of white matter hypertension in MRI
Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years
the development of lacunes in MRI
Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years
the development of enlarged perivascular space in MRI
Time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years
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 28 Sep 2023.
- Derived from this study: PubMed 40067051Hu F, Xie W, Fan M, Wang Y, Xu S, Qiu W, Yang T, Lv H, Huang H, Wu Y, Fu Y, Cai B. Intracerebral Hemorrhage in Autosomal Dominant Cerebral Arteriopathy With Subcortical Infarcts and Leukoencephalopathy. Eur J Neurol. 2025 Mar;32(3):e70100. doi: 10.1111/ene.70100.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Diseases, run by Bin Cai at 1 site in China.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Bin Cai, PhD (13338413842 ext. 86, caibin929@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall outcomes in patients with cerebral small vessel disease. (time frame: From date of enrollment until the date of death from any cause, assessed up to 30 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04318119, which also lists 1 linked publication.
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 28 Sep 2023; AzTrials last refreshed its copy on 1 Nov 2026.