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Fabry : National Initiative of Screening (FIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00484549
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : December 21, 2009
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment
Ischemic Stroke Hospitalized Procedure: Blood sample

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 889 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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.
Study Start Date : March 2007
Primary Completion Date : December 2008
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Blood sample
    Ischemic stroke hospitalized


Primary Outcome Measures :
  1. Fabry disease's screening (Positive microdosage confirmed by a macrodosage) [ Time Frame: Positive microdosage confirmed by a macrodosage ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484549


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

Publications:
Responsible Party: Pierre CLAVELOU, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00484549     History of Changes
Other Study ID Numbers: CHU63-0019
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: December 21, 2009
Last Verified: December 2009

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

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