Ischemic Stroke HospitalizedFINDNCT00484549
Fabry : National Initiative of Screening
A study testing Blood sample in people with Ischemic Stroke Hospitalized, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 55 years, men only
- Conditions the study is for
- Ischemic Stroke Hospitalized
- What is being tested?
- Blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 889 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 55 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Hospitalized ischemic stroke
- Written and signed informed consent from patient or legal representative
Who cannot join
- Patients belonging to a family which has a Fabry disease's diagnosis confirmed
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Ischemic Stroke Hospitalized
- Being tested
- Blood sample
- Keywords
- Fabry disease, Screening, Ischemic stroke
- Medical subject headings
- Fabry Disease, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Ischemic stroke hospitalized
What is being measured
The primary outcome is the main question the study is designed to answer.
Fabry disease's screening (Positive microdosage confirmed by a macrodosage)
Measured: Positive microdosage confirmed by a macrodosage
Secondary outcomes (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
Measured: patients affected by Fabry disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke HospitalizedStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 889 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Pierre Clavelou, Pr, Principal investigator, Unaffilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484549
- Sponsor's protocol ID
- CHU63-0019
- Acronym
- FIND
- Status last verified
- Dec 2009
- First submitted
- 8 Jun 2007
- Last updated
- 21 Dec 2009
- Results posted
- No
Publications
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.
PubMed 16710123
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00484549
- Acronym / sponsor ID
- FIND / CHU63-0019
- Conditions
- Ischemic Stroke Hospitalized
- Keywords
- Fabry disease, Screening, Ischemic stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 889 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 28 days to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Hospitalized ischemic stroke
- Written and signed informed consent from patient or legal representative
Key exclusion criteria (1 listed)
- Patients belonging to a family which has a Fabry disease's diagnosis confirmed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleIschemic stroke hospitalized | Procedure or surgery | – |
Primary outcome
Fabry disease's screening (Positive microdosage confirmed by a macrodosage)
Time frame: Positive microdosage confirmed by a macrodosage
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2009.
- Background: PubMed 16710123Clavelou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Clavelou, Pr principal investigator
Unaffilliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Ischemic Stroke Hospitalized, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fabry disease's screening (Positive microdosage confirmed by a macrodosage) (time frame: Positive microdosage confirmed by a macrodosage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00484549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2009.