Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
NCT ID: NCT05985213
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1078 participants
OBSERVATIONAL
2020-12-01
2028-12-31
Brief Summary
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Detailed Description
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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, and other related factors.
2. To explore and summarize the clinical and radiological characteristics of the CSVD population, and identify new risk factors for CSVD.
3. To investigate in depth the underlying mechanisms and the relationship between clinical and radiological outcomes in CSVD.
4. To establish a multifactor prediction model for cognitive and emotional disorders in CSVD.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CSVD patients
The neuroimaging diagnosis will follow the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria established by the neuroimaging experts in 2013. The interpretation and assessment will be conducted jointly by one experienced radiologist and one experienced neurologist.
data collection and follow-up
Main measures and data collection methods:
1. Recording of baseline demographic and clinical information of the participants.
2. Multimodal magnetic resonance imaging
3. blood pressure variability.
4. neuropsychological testing
5. Blood samples collection
Interventions
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data collection and follow-up
Main measures and data collection methods:
1. Recording of baseline demographic and clinical information of the participants.
2. Multimodal magnetic resonance imaging
3. blood pressure variability.
4. neuropsychological testing
5. Blood samples collection
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. Participants who are able to understand and agree to participate in the study, and have signed the informed consent form.
Exclusion Criteria
2. Intracranial and extracranial vascular examination confirms stenosis of the blood vessel by ≥50%.
3. Imaging data reveals intracranial space-occupying lesions.
4. 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).
5. Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory failure, renal failure, severe liver dysfunction, severe blood system diseases, or gastrointestinal bleeding.
6. Severe impairment in vision, hearing, language function, or limb muscular weakness that prevents completion of relevant tests.
7. Women who are pregnant or breastfeeding.
8. MRI scan contraindicated due to various reasons (such as claustrophobia).
9. Any other reasons that prevent the collection of clinical data required for this study.
18 Years
80 Years
ALL
Yes
Sponsors
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Shanghai Yueyang Integrated Medicine Hospital
OTHER
Responsible Party
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Principal Investigators
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Jia Zhou
Role: PRINCIPAL_INVESTIGATOR
Shanghai University of Traditional Chinese Medicine
Locations
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Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-128
Identifier Type: -
Identifier Source: org_study_id
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