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

NCT05985213 | Recruiting

• 1 other identifier: 2023-128
• Study Type: observational
• Target: 1,078
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Small Vessel Diseases

Outcome Measures

Primary Outcomes (1)

• Cognitive state

  The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale.

  2020-12-1 to 2027-12-31

Secondary Outcomes (2)

• Blood pressure variability

  2020-12-1 to 2027-12-31

• The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces.

  2020-12-1 to 2027-12-31

Study Arms (1)

CSVD patients

The neuroimaging diagnosis will follow the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria established by the neuroimaging experts in 2013. The interpretation and assessment will be conducted jointly by one experienced radiologist and one experienced neurologist.

Other: data collection and follow-up

Interventions

data collection and follow-up OTHER

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

CSVD patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CSVD

You may qualify if:

• Participants aged between 18 and 80 years, with no restriction on gender.
• 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.
• 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.
• Participants who are able to understand and agree to participate in the study, and have signed the informed consent form.

You may not qualify if:

• 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).
• Intracranial and extracranial vascular examination confirms stenosis of the blood vessel by ≥50%.
• Imaging data reveals intracranial space-occupying lesions.
• 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).
• Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory failure, renal failure, severe liver dysfunction, severe blood system diseases, or gastrointestinal bleeding.
• Severe impairment in vision, hearing, language function, or limb muscular weakness that prevents completion of relevant tests.
• Women who are pregnant or breastfeeding.
• MRI scan contraindicated due to various reasons (such as claustrophobia).
• Any other reasons that prevent the collection of clinical data required for this study.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

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

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Each patient will provide 2 tubes of fasting blood.

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jia Zhou

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yajing Huo

CONTACT

+86 188 1821 1605; heej07@126.com

Yan Han

CONTACT

+86 189 1751 0069; hanyan.2006@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: August 14, 2023
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)