Fabry Disease in the Young StrokeNCT01109875
Screening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic
A study testing blood test in people with Fabry Disease in the Young Stroke, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine the incidence of Fabry Disease in young stroke patients in an Israeli stroke clinic. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fabry Disease in the Young Stroke
- What is being tested?
- blood test
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to Dec 2014
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of stoke or TIA Time period within last 5 years -
Who cannot join
- Known diagnosis of stroke or index event due to trauma
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the incidence of Fabry Disease in young stroke patients in an Israeli stroke clinic.
- Conditions
- Fabry Disease in the Young Stroke
- Being tested
- blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testOther
Dry blood spots (DBS) analysis of a- galactosidase-A activity will be used for male patients' diagnosis. Males and females with enzymatic activity bellow the test's cut-off will be further diagnosed by gene sequencing. Since females are heterozygote and may have high residual levels of active enzyme, female patients with a- galactosidase-A activity of 30% bellow averaged normal range will also be further diagnosed by gene sequencing as described before (8).
What is being measured
The primary outcome is the main question the study is designed to answer.
positive screening of fabry disease
Measured: past 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fabry Disease in the Young StrokeStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Yair Lampl, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109875
- Sponsor's protocol ID
- 1
- Status last verified
- Jun 2014
- First submitted
- 22 Apr 2010
- Last updated
- 12 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Fabry Disease Among Young Stroke Patients in an Israeli Stroke Clinic
- ClinicalTrials.gov ID
- NCT01109875
- Acronym / sponsor ID
- 1
- Conditions
- Fabry Disease in the Young Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- May 2010
- Primary completion
- Dec 2014 (estimated)
- First posted
- 23 Apr 2010 (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.
The purpose of this study is to determine the incidence of Fabry Disease in young stroke patients in an Israeli stroke clinic.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosis of stoke or TIA Time period within last 5 years -
Key exclusion criteria (2 listed)
- Known diagnosis of stroke or index event due to trauma
- -
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 testDry blood spots (DBS) analysis of a- galactosidase-A activity will be used for male patients' diagnosis. Males and females with enzymatic activity bellow the test's cut-off will be further diagnosed by gene sequencing. Since females are heterozygote and may have high residual levels of active enzyme, female patients with a- galactosidase-A activity of 30% bellow averaged normal range will also be further diagnosed by gene sequencing as described before (8). | Other | – |
Primary outcome
positive screening of fabry disease
Time frame: past 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 test in people with Fabry Disease in the Young Stroke, run by Wolfson Medical Center at 1 site in Israel.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jun 2014. 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 Israel. 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?
Results are not available in the source record.
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?
positive screening of fabry disease (time frame: past 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2014.