RecruitingNCT04962295
China Imaging-based Biobank of Cerebral Small Vessal Diseases
Sponsor
Peking University Third Hospital
Enrollment
10,000 participants
Start Date
Oct 1, 2020
Study Type
OBSERVATIONAL
Conditions
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). 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.
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- 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
- 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.
Exclusion Criteria12
- 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
- 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
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Interventions
OTHERNo intervention
No intervention
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04962295
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