National imaging platform for cerebral small vessel diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University Third Hospital
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.