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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05985213
Other study ID # 2023-128
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2028

Study information

Verified date August 2023
Source Shanghai Yueyang Integrated Medicine Hospital
Contact Yajing Huo
Phone +86 188 1821 1605
Email heej07@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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, 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1078
Est. completion date December 31, 2028
Est. primary completion date December 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
data collection and follow-up
Main measures and data collection methods: Recording of baseline demographic and clinical information of the participants. Multimodal magnetic resonance imaging blood pressure variability. neuropsychological testing Blood samples collection

Locations

Country Name City State
China Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive state The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale. 2020-12-1 to 2027-12-31
Secondary Blood pressure variability 24-hour ambulatory blood pressure 2020-12-1 to 2027-12-31
Secondary The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces. If the fine structures are not clearly visible on the 3.0T MRI and further evaluation is needed for the clinical and therapeutic assessment of cerebral small vessel disease, the patient will be referred to undergo a 7.0T MRI examination. 2020-12-1 to 2027-12-31
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