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NCT Number: NCT04962295

China Imaging-based Biobank of Cerebral Small Vessal Diseases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, China

Location status: Recruiting

Location contact

Xiaogang Li

CONTACT

[email protected]

13501095002

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. The number of patients with each diagnosis.

    Time frame: At discharge, usually within two weeks.

    Detailed diagnosis of the patient's disease.

Secondary outcomes

  1. mRS score

    Time frame: during 5 years after diagnosis

    mRS score of patients

  2. New adverse vascular events

    Time frame: during 5 years after diagnosis

    New adverse vascular events

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Beijing Tiantan Hospital

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jul 14, 2021
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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