National imaging platform for cerebral small vessel diseases
China Imaging-based Biobank of Cerebral Small Vessal Diseases
This study is trying to create a new platform to collect and analyze brain scans and other health data from people with cerebral small vessel diseases to better understand the condition and find ways to identify those at higher risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04962295 on ClinicalTrials.gov |
What this trial studies
This study aims to create a comprehensive evaluation platform for cerebral small vessel diseases (CSVD) by longitudinally collecting imaging-based medical data from patients. It will assess various prognostic factors, including imaging signs, cognitive function, gait, and hemodynamics, to better understand the etiology and pathophysiological mechanisms of CSVD. The study will also propose new classification and diagnostic criteria for CSVD and establish a risk prediction model to identify high-risk populations early. The ultimate goal is to reduce the burden of CSVD in China.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with identifiable SVD lesions on MRI.
Not a fit: Patients without MRI-confirmed small vessel disease or those who are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early identification and management of patients at high risk for cerebral small vessel diseases.
How similar studies have performed: Other studies have shown promise in using imaging data to evaluate cerebral small vessel diseases, but this approach may offer novel insights and methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing
- Peking University Third Hospital — Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.