CADASIL Registry Study

NCT04310098 | Recruiting

• 1 other identifier: MRCTA,ECFAH of FMU [2019]244-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cadasil

Outcome Measures

Primary Outcomes (1)

• Overall outcomes in CADASIL patients

  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 Outcomes (1)

• The correlation of genotype and phenotype

  From date of enrollment until the date of death from any cause, assessed up to 20years

Study Arms (4)

CADASIL patients

Asymptomatic carriers of CADASIL

Relatives of CADASIL patients and carriers

Unrelated healthy controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed in hosipital and their's family

You may qualify if:

• Sign informed consent.
• Age\>18
• Clinical diagnosis of patients with CADASIL,and confirmed by genetic test or skin biopsy
• Asymptomatic NOTCH3 mutation carriers
• Relatives of CADASIL patients or carriers
• Unrelated healthy controls

You may not qualify if:

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

Sponsors & Collaborators

• Bin Cai: lead

Study Sites (1)

Department of Neurology , First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350004, China

RECRUITING

MeSH Terms

Conditions

CADASIL

Condition Hierarchy (Ancestors)

Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Small Vessel Diseases; Dementia, Vascular; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Dementia; Vascular Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Lin Yi, PhD

CONTACT

13615039153; caibin929@163.com

Cai Bin, PhD

CONTACT

13338413842; caibin929@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 17, 2020
• Study Start: March 9, 2020
• Primary Completion (Estimated): March 9, 2039
• Study Completion (Estimated): March 9, 2049
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)