Status:
RECRUITING
Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
Lead Sponsor:
Shanghai Yueyang Integrated Medicine Hospital
Conditions:
Cerebral Small Vessel Diseases
Eligibility:
All Genders
18-80 years
Brief Summary
This cohort study involves the dynamic collection of clinical information, including serum parameters , blood pressure variability, imaging data, and neuropsychological scales, in patients with cerebr...
Detailed Description
Research Objectives: 1. To conduct a longitudinal study on patients with cerebral small vessel disease (CSVD) and observe the dynamic evolution of their cognitive functioning, emotional disorders, an...
Eligibility Criteria
Inclusion
- Participants aged between 18 and 80 years, with no restriction on gender.
- Participants who have completed a 3.0T MRI of the head within one year at Yueyang Hospital, and meet the imaging diagnostic criteria of the 2013 STRIVE guidelines.
- Participants who have a Modified Rankin Scale (mRS) score of 0-2 (able to perform activities of daily living) at the time of the visit.
- Participants who are able to understand and agree to participate in the study, and have signed the informed consent form.
Exclusion
- Diagnosis of symptomatic lacunar syndrome without 6 months of onset (participants can be enrolled after 6 months to avoid the impact of the acute phase).
- Intracranial and extracranial vascular examination confirms stenosis of the blood vessel by ≥50%.
- Imaging data reveals intracranial space-occupying lesions.
- A history of other neurological or mental illnesses with a definite diagnosis of the cause, including stroke (excluding lacunar infarctions), neurodegenerative diseases (such as Parkinson's disease and Alzheimer's disease).
- Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory failure, renal failure, severe liver dysfunction, severe blood system diseases, or gastrointestinal bleeding.
- Severe impairment in vision, hearing, language function, or limb muscular weakness that prevents completion of relevant tests.
- Women who are pregnant or breastfeeding.
- MRI scan contraindicated due to various reasons (such as claustrophobia).
- Any other reasons that prevent the collection of clinical data required for this study.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
1078 Patients enrolled
Trial Details
Trial ID
NCT05985213
Start Date
December 1 2020
End Date
December 31 2028
Last Update
August 14 2023
Active Locations (1)
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1
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, China