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Fabry : National Initiative of Screening (FIND)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00484549
First received: June 8, 2007
Last updated: December 18, 2009
Last verified: December 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

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
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Blood sample
    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

Locations
France
Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Pierre Clavelou, Pr Unaffilliated
  More Information

Publications:

Responsible Party: Pierre CLAVELOU, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00484549     History of Changes
Other Study ID Numbers: CHU63-0019
Study First Received: June 8, 2007
Last Updated: December 18, 2009
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Fabry disease, Screening, Ischemic stroke

Additional relevant MeSH terms:
Fabry Disease
Ischemia
Stroke
Cerebral Infarction
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
 Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on June 17, 2013