Cerebral Small Vessel DiseasesNCT04962295
China Imaging-based Biobank of Cerebral Small Vessal Diseases
An observational study of Cerebral Small Vessel Diseases, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to build a national image-based comprehensive evaluation platform of CSVD through longitudinal collection of imaging based medical data of patients with cerebral small vessel diseases (CSVD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Small Vessel Diseases
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Cerebral Small Vessal Diseases patients
Who may be able to join
- Age ≥ 18 years old
- SVD lesions can be seen on MRI of the head
- White matter hyperintensity, Fazekas score ≥ 2
- Fazekas=1 has more than 2 vascular risk factors (hypertension, hyperlipidemia, diabetes, obesity, smoking, and other vascular events except stroke).
- Fazekas = 1 and combined with lacunar focus
- Imaging findings suggest new subcortical lacunar infarction
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- Daily life independence (MRS ≤ 2)
- Sign informed consent
- Note: the imaging definition of small vessel disease refers to the strong guideline
- The total score of Fazekas was 6, which was the sum of Fazekas scores of subcortical and periventricular white matter lesions.
- New subcortical lacunar infarction: head MRI examination, subcortical, basal ganglia or brain stem DWI showed high signal (ADC diffusion limited) lesions with diameter < 20 mm, with or without corresponding clinical symptoms; There were new clinical symptoms. FLAIR sequence of head MRI showed flair hyperintense lesions (diameter < 20 mm) in subcortical, basal ganglia or pons.
Who cannot join
- In acute cerebral infarction, the lesions showed high signal intensity on DWI, and the diameter was more than 20 mm
- Acute cerebral hemorrhage
- Acute subarachnoid hemorrhage, or previous history of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage,
- Or untreated aneurysms (> 3mm in diameter) were found
- Neurodegenerative diseases, such as AD and PD, have been diagnosed
- There are clear non angiogenic white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy
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- Diseases, etc
- Mental disorders diagnosed according to DSM-V diagnostic criteria
- Contraindications of MRI examination (such as claustrophobia)
- With severe organic diseases, such as malignant tumor, the expected survival time is less than 5 years
- Due to geographical or other reasons can not cooperate to complete the follow-up
- Patients also participated in other clinical trials
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
Peking University Third Hospital
Beijing
Xiaogang Li, 13501095002, bysy@bjmu.edu.cn
About this study
The purpose of this study is to build a national image-based comprehensive evaluation platform of CSVD through longitudinal collection of imaging based medical data of patients with cerebral small vessel diseases (CSVD). On this basis, the new classification and diagnostic criteria of CSVD are proposed, and the risk prediction model of CSVD is established. By evaluating the prognostic factors of CSVD, early identification of high-risk CSVD population.
Read the detailed description
The purpose of this study is to build a national image-based CSVD comprehensive evaluation platform by collecting the medical data of patients with cerebral small vessel diseases (CSVD) based on imaging longitudinally, and to evaluate the risk factors of each type of CSVD, as well as imaging signs, cognition, gait, autonomic nervous system and hemodynamics, sleep, sleep, and so on The outcome of emotion and fundus. In the fields of imaging, molecular and neurocognitive function, we explored the etiology and pathophysiological mechanism of CSVD, proposed new classification and diagnostic criteria of CSVD, and established the risk prediction model of CSVD. By evaluating the prognostic factors of CSVD, early identification of high-risk CSVD population, in order to reduce the burden of CSVD in China in the future.
- Conditions
- Cerebral Small Vessel Diseases
- 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 |
|---|---|---|
| Cerebral Small Vessel Diseases group | CSVD patients Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with each diagnosis.
Detailed diagnosis of the patient's disease.
Measured: At discharge, usually within two weeks.
Secondary outcomes (2)
mRS score
mRS score of patients
Measured: during 5 years after diagnosis
New adverse vascular events
New adverse vascular events
Measured: during 5 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Oct 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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 DiseasesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962295
- Sponsor's protocol ID
- M2021248
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Imaging-based Biobank of Cerebral Small Vessal Diseases
- ClinicalTrials.gov ID
- NCT04962295
- Acronym / sponsor ID
- M2021248
- Conditions
- Cerebral Small Vessel Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jul 2021 (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 purpose of this study is to build a national image-based comprehensive evaluation platform of CSVD through longitudinal collection of imaging based medical data of patients with cerebral small vessel diseases (CSVD). On this basis, the new classification and diagnostic criteria of CSVD are proposed, and the risk prediction model of CSVD is established. By evaluating the prognostic factors of CSVD, early identification of high-risk CSVD population.
Detailed description
The purpose of this study is to build a national image-based CSVD comprehensive evaluation platform by collecting the medical data of patients with cerebral small vessel diseases (CSVD) based on imaging longitudinally, and to evaluate the risk factors of each type of CSVD, as well as imaging signs, cognition, gait, autonomic nervous system and hemodynamics, sleep, sleep, and so on The outcome of emotion and fundus. In the fields of imaging, molecular and neurocognitive function, we explored the etiology and pathophysiological mechanism of CSVD, proposed new classification and diagnostic criteria of CSVD, and established the risk prediction model of CSVD. By evaluating the prognostic factors of CSVD, early identification of high-risk CSVD population, in order to reduce the burden of CSVD in China in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Small Vessel Diseases group | – | Other: No interventionCSVD patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cerebral Small Vessal Diseases patients
Key inclusion criteria (11 listed)
- Age ≥ 18 years old
- SVD lesions can be seen on MRI of the head
- Daily life independence (MRS ≤ 2)
- Sign informed consent
- Note: the imaging definition of small vessel disease refers to the strong guideline
Key exclusion criteria (12 listed)
- In acute cerebral infarction, the lesions showed high signal intensity on DWI, and the diameter was more than 20 mm
- Acute cerebral hemorrhage
- Acute subarachnoid hemorrhage, or previous history of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage,
- Or untreated aneurysms (> 3mm in diameter) were found
- Neurodegenerative diseases, such as AD and PD, have been diagnosed
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 | Cerebral Small Vessel Diseases group |
Primary outcome
The number of patients with each diagnosis.
Time frame: At discharge, usually within two weeks.
Detailed diagnosis of the patient's disease.
2 secondary outcomes
mRS score
Time frame: during 5 years after diagnosis
New adverse vascular events
Time frame: during 5 years after diagnosis
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 14 Jul 2021.
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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 Peking University Third Hospital 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 11 inclusion and 12 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 14 Jul 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with each diagnosis. (time frame: At discharge, usually within two weeks.). 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 14 Jul 2021.