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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05985213
Enrollment
1078
Registered
2023-08-14
Start date
2020-12-01
Completion date
2028-12-31
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Small Vessel Diseases

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 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.

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, 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.

Interventions

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

Sponsors

Shanghai Yueyang Integrated Medicine Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive state2020-12-1 to 2027-12-31The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale.

Secondary

MeasureTime frameDescription
Blood pressure variability2020-12-1 to 2027-12-3124-hour ambulatory blood pressure
The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces.2020-12-1 to 2027-12-31If 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.

Countries

China

Contacts

Primary ContactYajing Huo
heej07@126.com+86 188 1821 1605
Backup ContactYan Han
hanyan.2006@aliyun.com+86 189 1751 0069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026