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Cerebral Small Vessel Disease Registry Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318119
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bin Cai, First Affiliated Hospital of Fujian Medical University

Brief Summary:
The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Small Vessel Disease (CSVD) and in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CSVD, , to find independent imaging markers, and to optimize clinical management.

Condition or disease
Cerebral Small Vessel Diseases

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: Cerebral Small Vessel Disease Registry Study
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : November 18, 2049
Estimated Study Completion Date : November 18, 2055



Primary Outcome Measures :
  1. Overall outcomes in patients with cerebral small vessel disease. [ Time Frame: From date of enrollment until the date of death from any cause, assessed up to 30 years ]
    record the occurrence of stroke and use modified Rankin Scale (mRS) to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.


Secondary Outcome Measures :
  1. the development of the burden of microbleeds in MRI [ Time Frame: From date of enrollment until the date of death from any cause, assessed up to 30 years ]
    using MARS scale to evaluate the development of the burden of microbleeds

  2. the development of the burden of white matter hypertension in MRI [ Time Frame: From date of enrollment until the date of death from any cause, assessed up to 30 years ]
    using Fazakes scale to evaluate the development of the burden of white matter hypertension

  3. the development of lacunes in MRI [ Time Frame: From date of enrollment until the date of death from any cause, assessed up to 30 years ]
    record the number and location of lacunes

  4. the development of enlarged perivascular space in MRI [ Time Frame: From date of enrollment until the date of death from any cause, assessed up to 30 years ]
    record the number and location of enlarged perivascular space



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who are diagnosed as Cerebral Small Vessel Disease
Criteria

Inclusion Criteria:

  1. Sign informed consent.
  2. Age>18
  3. At least one of the following CSVD MRI characteristics: ①recent small subcortical infarct;②lacune of presumed vascular origin;③white matter hypertensity of presumed vascular origin;④perivascular space;⑤cerebral microbleeds;⑥brain atrophy

Exclusion Criteria:

  1. Unable to cooperate with inspectors
  2. Non-vascular white matter lesions
  3. Other cognitive diseases (such as alzheimer's disease, Parkinson's disease or thyroid disease)
  4. Serious systemic illness, such as heart, liver, kidney disease or major mental illness
  5. Contraindications for imaging examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318119


Contacts
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Contact: Bin Cai, PhD 13338413842 ext 86 caibin929@163.com

Locations
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China, Fujian
Department of Neurology , First Affiliated Hospital Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350004
Contact: Cai Bin    13338413842 ext 86    caibin929@163.com   
Sponsors and Collaborators
Bin Cai
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Responsible Party: Bin Cai, Professor, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT04318119    
Other Study ID Numbers: MRCTA,ECFAH of FMU [2019]245
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases