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RecruitingNCT05985213Updated Aug 14, 2023

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

An observational study in Cerebral Small Vessel Diseases, sponsored by Shanghai Yueyang Integrated Medicine Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Observational

From the registry’s dates

  • Started Dec 2020; still recruiting 5 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,078
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Cerebral Small Vessel Diseases
03

In context

Cerebral Small Vessel Diseases

121 studies on the registry are indexed under Cerebral Small Vessel Diseases; 66 are open to participants now.

This study's planned enrollment of 1,078 is above the median of 300 across 52 observational studies indexed under Cerebral Small Vessel Diseases.

Browse Cerebral Small Vessel Diseases studies →

Lead sponsor

Shanghai Yueyang Integrated Medicine Hospital is the lead sponsor of 35 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with CSVD

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,078 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Otherdata collection and follow-up

    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

06

What researchers measure

Primary outcomes

  1. Cognitive state

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

    Time frame: 2020-12-1 to 2027-12-31

Secondary outcomes

  1. Blood pressure variability

    24-hour ambulatory blood pressure

    Time frame: 2020-12-1 to 2027-12-31

  2. 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.

    Time frame: 2020-12-1 to 2027-12-31

07

Study locations

1 of 1 sites recruiting
  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
    Shanghai, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05985213
Lead sponsor
Shanghai Yueyang Integrated Medicine Hospital
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Dec 1, 2020
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 14, 2023

Study contacts

Yajing Huo
Contact
heej07@126.com
+86 188 1821 1605
Yan Han
Contact
hanyan.2006@aliyun.com
+86 189 1751 0069
Jia Zhou
principal investigator · Shanghai University of Traditional Chinese Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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