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Clinical Trials in China / NCT04962295
Recruiting Observational

China Imaging-based Biobank of Cerebral Small Vessal Diseases

NCT04962295 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Third Hospital
Phase
Observational
Started
2020-10-01
Last updated
2021-07-14

Condition(s) studied

Cerebral Small Vessel Diseases

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years old 2. 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 3. Daily life independence (MRS ≤ 2) 4. Sign informed consent Note: the imaging definition of small vessel disease refers to the strong guideline 1. The total score of Fazekas was 6, which was the sum of Fazekas scores of subcortical and periventricular white matter lesions. 2. 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 Criteria: 1. In acute cerebral infarction, the lesions showed high signal intensity on DWI, and the diameter was more than 20 mm 2. Acute cerebral hemorrhage 3. Acute subarachnoid hemorrhage, or previous history of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage, Or untreated aneurysms (\> 3mm in diameter) were found 4. Neurodegenerative diseases, such as AD and PD, have been diagnosed 5. There are clear non angiogenic white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy Diseases, etc 6. Mental disorders diagnosed according to DSM-V diagnostic criteria 7. Contraindications of MRI examination (such as claustrophobia) 8. With severe organic diseases, such as malignant tumor, the expected survival time is less than 5 years 9. Due to geographical or other reasons can not cooperate to complete the follow-up 10. Patients also participated in other clinical trials

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04962295 on ClinicalTrials.gov ↗ ← All trials in China