Status:
UNKNOWN
Development of New Biomarkers With Magnetic Resonance Imaging for Longitudinal Studies in CADASIL Angiopathy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cadasil
Angiopathy; Cerebral
Eligibility:
All Genders
18-80 years
Brief Summary
CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy) is an cerebral microangiopathy secondary to mutations in the NOTCH3 gene located on chromosome 19. ...
Eligibility Criteria
Inclusion
- Patients
- Age from 18 to 80 years
- Confirmed diagnosis (detection of a pathogenic mutation of the NOTCH3 gene)
- Detailed clinical and MRI assessment of the disease (follow-up at the CERVCO) including Rankin score \<4
- Any contraindication to MRI or EEG examination (claustrophobia, presence of material with magnetic properties)
- Social security insurance
- Written consent.
- Controls
- Age from 18 to 80 years
- No history of neurological or psychiatric diseases
- No history of migraine with aura
- No history of vascular disease (peripheral arteries, heart, brain)
- No known or treated diabetes
- No known or treated hypercholesterolemia
- Social security insurance
- Written consent
Exclusion
- Patients
- Patients with a contraindication to MRI or EEG examination (claustrophobia, material with magnetic properties: pacemaker, ferromagnetic material ...)
- For MRI examination of neurovascular coupling: Patients with a treatment that may interfere with neurovascular coupling (in particular any treatment with non-steroidal anti-inflammatory drugs, psychotropic drugs, antihypertensive agents or statins)
- Patients without a social security insurance
- Patients under the age of 18 or over 80 at the time of the first visit
- Patients unable to give their informed consent
- Person referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-12 of the Public Health Code, defined by:
- Pregnant, parturient or nursing woman
- Person deprived of liberty by judicial or administrative decision
- Person hospitalized without consent and not subject to a legal protection measure, and person admitted to a health or social institution for purposes other than research
- Minor
- Adult under legal protection measure (guardianship, guardianship or court order), an adult unable to express their consent and not subject to a protective measure
- Person submitted to an exclusion period for another research (washout period)
- Controls
- Subject with a contraindication to MRI or EEG examination (claustrophobia, material with magnetic properties: pacemaker, ferromagnetic material ...)
- For MRI examination of neurovascular coupling: Subject with a treatment that may interfere with neurovascular coupling (in particular any treatment with non-steroidal anti-inflammatory drugs, psychotropic drugs, antihypertensive agents or statins)
- Subject without a social security insurance
- Subject under the age of 18 or over 80 years at the time of the first visit
- Patients unable to give their informed consent
- Person referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-12 of the Public Health Code, defined by:
- Pregnant, parturient or nursing woman
- Person deprived of liberty by judicial or administrative decision
- Person hospitalized without consent and not subject to a legal protection measure, and person admitted to a health or social institution for purposes other than research
- Minor
- Adult under legal protection measure (guardianship, guardianship or court order), an adult unable to express their consent and not subject to a protective measure
- Person submitted to an exclusion period for another research study (washout period)
Key Trial Info
Start Date :
August 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 6 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04036084
Start Date
August 10 2019
End Date
January 6 2023
Last Update
August 18 2020
Active Locations (1)
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1
Lariboisiere hospital
Paris, France, 75010