NCT00484549CompletedNot Applicable
National, Multicenter, Prospective Study of Screening of Fabry Disease in a Population of Men Over 28 Days Old and Less Than 55 Years, Hospitalized for an Ischemic Stroke.
University Hospital, Clermont-Ferrand2 sites in 1 country889 target enrollmentStarted: March 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 889
- Locations
- 2
- Primary Endpoint
- Fabry disease's screening (Positive microdosage confirmed by a macrodosage)
Study Overview
Brief Summary
Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of life threatening manifestations such as an ischemic stroke.
The purpose of the study is to determinate the prevalence of Fabry disease in a population of male patients hospitalized for an ischemic stroke.
This study, with a screening of Fabry disease, allows the patients to make a precise diagnosis of their ischemic stroke and to facilitate the screening of the other members at the facility.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 28 Days to 55 Years (Child, Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospitalized ischemic stroke
- •Written and signed informed consent from patient or legal representative
Exclusion Criteria
- •Patients belonging to a family which has a Fabry disease's diagnosis confirmed
Outcomes
Primary Outcomes
Fabry disease's screening (Positive microdosage confirmed by a macrodosage)
Time Frame: Positive microdosage confirmed by a macrodosage
Secondary Outcomes
- Describe and compare the characteristics of patients affected by Fabry disease and patients who are not affected Identify clinical and neuroradiological predictive elements of Fabry disease(patients affected by Fabry disease)
Investigators
Study Sites (2)
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