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

August 9, 2023 updated by: Shanghai Yueyang Integrated Medicine Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1078

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yajing Huo
  • Phone Number: +86 188 1821 1605
  • Email: heej07@126.com

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with CSVD

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive state
Time Frame: 2020-12-1 to 2027-12-31
The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale.
2020-12-1 to 2027-12-31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure variability
Time Frame: 2020-12-1 to 2027-12-31
24-hour ambulatory blood pressure
2020-12-1 to 2027-12-31
The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces.
Time Frame: 2020-12-1 to 2027-12-31
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Yueyang Integrated Medicine Hospital

Investigators

  • Principal Investigator: Jia Zhou, Shanghai University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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