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Fabry : National Initiative of Screening (FIND)

Primary Purpose

Ischemic Stroke Hospitalized

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke Hospitalized focused on measuring Fabry disease, Screening, Ischemic stroke

Eligibility Criteria

28 Days - 55 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Gabriel Montpied

Outcomes

Primary Outcome Measures

Fabry disease's screening (Positive microdosage confirmed by a macrodosage)

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

Full Information

First Posted
June 8, 2007
Last Updated
December 18, 2009
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT00484549
Brief Title
Fabry : National Initiative of Screening
Acronym
FIND
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 Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke Hospitalized
Keywords
Fabry disease, Screening, Ischemic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
889 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
Ischemic stroke hospitalized
Primary Outcome Measure Information:
Title
Fabry disease's screening (Positive microdosage confirmed by a macrodosage)
Time Frame
Positive microdosage confirmed by a macrodosage
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Clavelou, Pr
Organizational Affiliation
Unaffilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16710123
Citation
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.
Results Reference
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Fabry : National Initiative of Screening

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