Clinical trial NCT05985213: Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
Official title: Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Small Vessel Diseases
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 1078
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CSVD

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.

Eligibility criteria: 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 outcomes:
measure: Cognitive state
timeFrame: 2020-12-1 to 2027-12-31
Secondary outcomes:
measure: Blood pressure variability
timeFrame: 2020-12-1 to 2027-12-31
measure: The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces.
timeFrame: 2020-12-1 to 2027-12-31
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jia Zhou
role: PRINCIPAL_INVESTIGATOR
References: