Fabry : National Initiative of Screening - Full Text View

Sponsored by:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00484549

Purpose

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.

Condition	Intervention
Ischemic Stroke Hospitalized	Procedure: Blood sample

Genetics Home Reference related topics: Fabry disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Efficacy Study
Official 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.

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Fabry disease's screening (Positive microdosage confirmed by a macrodosage) [ Time Frame: Positive microdosage confirmed by a macrodosage ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: patients affected by Fabry disease ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	889
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Ischemic stroke hospitalized

Eligibility

Ages Eligible for Study:	up to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484549

Contacts

Contact: Pierre Clavelou, Pr	04.73.75.22.01	pclavelou@chu-clermontferrand.fr
Contact: Dominique P Germain + Boucly, Pr		dominique.germain@rpc.aphp.fr

Locations

France
Hôpital Gabriel Montpied	Recruiting
Clermont-Ferrand, France, 63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator:

Pierre Clavelou, Pr

Unaffilliated

More Information

Publications:

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.

Responsible Party:	CHU Clermont-Ferrand ( Pierre CLAVELOU )
Study ID Numbers:	CHU63-0019
Study First Received:	June 8, 2007
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00484549
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Fabry disease, Screening, Ischemic stroke

Study placed in the following topic categories:

Ceramide trihexosidosis
Cerebral Infarction
Stroke
Fabry Disease
Fabry disease

Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009