Actively Recruiting
Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
Led by Shanghai Yueyang Integrated Medicine Hospital · Updated on 2023-08-14
1078
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a cohort study to observe patients with cerebral small vessel disease (CSVD), focusing on how their cognitive functions and emotional health change over time. The study aims to describe the clinical and imaging features of CSVD, identify new risk factors, and understand the links between clinical symptoms and imaging results. Additionally, it seeks to develop a prediction model for cognitive and mood disorders in CSVD patients. Participants will undergo various assessments including multimodal magnetic resonance imaging following established STRIVE criteria, blood pressure variability measurements, neuropsychological testing, and blood sample collection. An experienced radiologist and neurologist will jointly interpret imaging results. Data collection and follow-up will capture dynamic clinical and imaging changes during the study period. Participants will provide baseline demographic and clinical information and complete tests to assess cognition, mood, and blood pressure variability. The study will monitor changes in white matter abnormalities and other brain imaging markers. Follow-up will continue until the end of 2027 to track cognitive state and related outcomes. This observational study allows researchers to closely study CSVD progression and related factors over several years.
CONDITIONS
Brief Title
Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Completed a 3.0T MRI of the head within the past year meeting the 2013 STRIVE imaging criteria
- Modified Rankin Scale score of 0 to 2 indicating ability to perform daily activities
- Able to understand the study and provide informed consent
You will not qualify if you...
- Diagnosis of symptomatic lacunar syndrome less than 6 months ago
- Blood vessel stenosis of 50% or more confirmed by vascular examination
- Presence of intracranial space-occupying lesions on imaging
- History of other neurological or mental illnesses with known causes, including stroke (excluding lacunar infarctions) and neurodegenerative diseases
- Serious illnesses like malignant tumors, heart failure, respiratory failure, kidney or liver failure, severe blood diseases, or gastrointestinal bleeding
- Severe vision, hearing, speech impairments, or limb weakness preventing test completion
- Pregnancy or breastfeeding
- Contraindications to MRI such as claustrophobia
- Any other factors preventing collection of required clinical data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 years
Participants with cerebral small vessel disease are observed over time to track changes in cognitive functioning, emotional disorders, blood pressure variability, and neuroimaging markers.
Regular assessments including neuropsychological testing, MRI scans, blood sample collections, and blood pressure monitoring throughout the study period
Trial Site Locations
Total: 1 location
1
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, China
Actively Recruiting
Research Team
Y
Yajing Huo
Y
Yan Han
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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