Fabry : National Initiative of Screening (FIND)

December 18, 2009 updated by: University Hospital, Clermont-Ferrand

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

889

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fabry disease's screening (Positive microdosage confirmed by a macrodosage)
Time Frame: Positive microdosage confirmed by a macrodosage
Positive microdosage confirmed by a macrodosage

Secondary Outcome Measures

Outcome Measure
Time Frame
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
patients affected by Fabry disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Pierre Clavelou, Pr, unaffilliated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 8, 2007

First Submitted That Met QC Criteria

June 8, 2007

First Posted (Estimate)

June 11, 2007

Study Record Updates

Last Update Posted (Estimate)

December 21, 2009

Last Update Submitted That Met QC Criteria

December 18, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU63-0019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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