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

Cerebral Small Vessel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985213
• Other study ID #: 2023-128
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases

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