Actively Recruiting

Age: 18Years +
All Genders
ID04962295

China Imaging-based Biobank of Cerebral Small Vessel Diseases A National Study to Evaluate Imaging and Clinical Outcomes

Led by Peking University Third Hospital · Updated on 2021-07-14

10000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

P

Peking University Third Hospital

Lead Sponsor

B

Beijing Tiantan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are building a national comprehensive platform to evaluate cerebral small vessel diseases (CSVD) by collecting imaging-based medical data over time. This study aims to propose new classification and diagnostic criteria, establish risk prediction models, and identify high-risk populations early to reduce the future burden of CSVD in China. The study explores multiple factors including imaging signs, cognition, gait, autonomic nervous system, hemodynamics, sleep, emotion, and eye health. Participants with CSVD will be observed without intervention. The study involves longitudinal data collection including imaging and clinical assessments. The primary group consists of patients with CSVD as identified by MRI. Data on different CSVD types and their risk factors will be gathered to support the development of new diagnostic and prognostic tools. During participation, patients will undergo evaluations including MRI scans and assessments of neurological function, cognition, gait, and other health measures. Researchers will monitor outcomes such as the number of patients diagnosed, functional status (mRS score) over five years, and new vascular events. Participation involves long-term follow-up to study disease progression and outcomes, with no treatment administered as part of the study.

CONDITIONS

Brief Title

China Imaging-based Biobank of Cerebral Small Vessal Diseases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Evidence of small vessel disease lesions on head MRI, including white matter hyperintensity with Fazekas score 2 or higher
  • Fazekas score 1 with more than 2 vascular risk factors or combined with lacunar focus
  • Imaging signs of new subcortical lacunar infarction
  • Independent in daily life with modified Rankin Scale (mRS) score of 2 or less
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Acute cerebral infarction with lesion larger than 20 mm on DWI
  • Acute cerebral hemorrhage
  • Acute or previous subarachnoid hemorrhage, cerebrovascular malformations, or untreated aneurysms larger than 3 mm
  • Diagnosed neurodegenerative diseases such as Alzheimer's or Parkinson's disease
  • Non-angiogenic white matter lesions like multiple sclerosis or metabolic encephalopathy
  • Mental disorders diagnosed by DSM-V criteria
  • Contraindications to MRI such as claustrophobia
  • Severe organic diseases including malignant tumors with expected survival less than 5 years
  • Unable to complete follow-up due to geographic or other reasons
  • Participation in other clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 weeks

Participants undergo imaging and clinical assessments to evaluate cerebral small vessel diseases and related factors.

1 to 2 visits depending on assessments

Long-term Monitoring

Duration - Up to 5 years after diagnosis

Participants are monitored over several years to evaluate clinical outcomes such as vascular events and functional status.

Periodic visits during 5 years for outcome assessments

Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, China

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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