Fabry : National Initiative of Screening

NCT ID: NCT00484549

Last Updated: 2009-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

889 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke Hospitalized

Keywords

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Fabry disease, Screening, Ischemic stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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Blood sample

Ischemic stroke hospitalized

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

28 Days

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Pierre Clavelou, Pr

Role: PRINCIPAL_INVESTIGATOR

Unaffilliated

Locations

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Hôpital Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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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. doi: 10.1016/s0035-3787(06)75051-2. French.

Reference Type BACKGROUND
PMID: 16710123 (View on PubMed)

Other Identifiers

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CHU63-0019

Identifier Type: -

Identifier Source: org_study_id