CADASIL Registry Study

September 26, 2023 updated by: Bin Cai

Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy Registry Study

The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) and related disorders in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CADASIL , to optimize clinical management.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

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

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350004
        • Recruiting
        • Department of Neurology , First Affiliated Hospital Fujian Medical University
        • 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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed in hosipital and their's family

Description

Inclusion Criteria:

  1. Sign informed consent.
  2. Age>18
  3. Clinical diagnosis of patients with CADASIL,and confirmed by genetic test or skin biopsy
  4. Asymptomatic NOTCH3 mutation carriers
  5. Relatives of CADASIL patients or carriers
  6. Unrelated healthy controls

Exclusion Criteria:

  1. Unable to cooperate with inspectors
  2. Serious systemic illness, such as heart, liver, kidney disease or major mental illness
  3. Contraindications for imaging examination

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Unrelated healthy controls
CADASIL patients
Asymptomatic carriers of CADASIL
Relatives of CADASIL patients and carriers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall outcomes in CADASIL patients
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 20years
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.
From date of enrollment until the date of death from any cause, assessed up to 20years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation of genotype and phenotype
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 20years
Genotype is defined by NOTCH3 pathogenic variant position and phenotype is defined by clinical types and characteristics.
From date of enrollment until the date of death from any cause, assessed up to 20years

Collaborators and Investigators

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

Sponsor

Bin Cai

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)

March 9, 2020

Primary Completion (Estimated)

March 9, 2039

Study Completion (Estimated)

March 9, 2049

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 14, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCTA,ECFAH of FMU [2019]244-1

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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