Ischemic Stroke Hospitalized Clinical Trial
— FINDOfficial title:
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.
| Verified date | December 2009 |
| Source | University Hospital, Clermont-Ferrand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 889 |
| Est. completion date | December 2009 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A to 55 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Gabriel Montpied | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
Clavelou P, Besson G, Elziere C, Ferrier A, Pinard JM, Hermier M, Artigou JY, Germain DP. [Neurological aspects of Fabry's disease]. Rev Neurol (Paris). 2006 May;162(5):569-80. Review. French. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fabry disease's screening (Positive microdosage confirmed by a macrodosage) | Positive microdosage confirmed by a macrodosage | Yes | |
| Secondary | 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 | Yes |