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Clinical Trials in China / NCT05985213
Recruiting Observational

Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease

NCT05985213 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Phase
Observational
Started
2020-12-01
Last updated
2023-08-14

Condition(s) studied

Cerebral Small Vessel Diseases

Investigational drug(s) / intervention(s)

data collection and follow-up

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

Study 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 cerebral small vessel disease (CSVD). The study aims to summarise the clinical and imaging characteristics of the CSVD population and identify novel CSVD risk factors. Additionally, this study intend to uncover the mechanisms underlying the clinical and imaging outcomes of CSVD. Furthermore, a multivariable prediction model for cognitive and mood disorders in patients with CSVD will be established.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Participants aged between 18 and 80 years, with no restriction on gender. 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: 1. 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). 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05985213 on ClinicalTrials.gov ↗ ← All trials in China