Cerebrovascular AccidentFASEPNCT01182818
Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
An observational study of Cerebrovascular Accident and Stroke, Acute, run by University of Rostock at 14 sites in 2 countries.
Trial summary
More than one million people in Europe suffer from a stroke every day. Normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. Usually, these can only be explained for a minority by the classical risk factors such as diabetes, overweight and high blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cerebrovascular Accident, Stroke, Acute, Cerebral Stroke
- How many people
- 1,000 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Sep 2010to Apr 2012
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients with acute ischemic cerebrovascular event of any ischemic etiology
Who may be able to join
- Adult patients (18 - 60 years of age) with an acute ischemic cerebrovascular event either acute ischemic stroke or transient ischemic attack within 10 days
- Diagnosis of the cerebrovascular event (CVE) by a stroke experienced physician
- Diagnostic procedures for CVE according to the local guidelines and recommendations
- Written informed consent from patient or legal representative according to local regulations
Who cannot join
- Patients being younger than 18 years or older than 60 years of age.
- Acute ischemic stroke or transient ischemic attack longer than 10 days before enrollment into the study
- CVE associated with intracranial hemorrhage as evidenced by cerebral CT scan
- Any uncertainty in the diagnosis
- No written informed consent from the patient or legal representative
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Germany13 sites
Department of Neurology, Kreiskrankenhaus Altenburg
Altenburg, 04600
Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln
Berlin, 12351
Department of Neurology, Allgemeines Krankenhaus Celle
Celle, 29223
Department of Neurology, Klinikum Chemnitz gGmbH
Chemnitz, 09131
Heinrich-Heine University Duesseldorf, Dept. of Neurology
Düsseldorf, D-40225
Universitätsklinikum Giessen, Department of Neurology
Giessen, 35392
Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universität Heidelberg, Klinik für Neurologie
Heidelberg, 69120
Department of Neurology, Universitaetsklinikum Jena
Jena, 07740
Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH
Mühlhausen / Thürigen, 99974
Universitätsklinikum Regensburg, Klinik für Neurologie
Regensburg, 93053
University of Rostock, Department of Neurology
Rostock, D-18055
University of Ulm, Department of Neurology
Ulm, D-89081
Poland1 site
Institute of Psychiatry and Neurology, Dept. of Neurology
Warsaw, 02-957
About this study
Official title: FASEP Fabry and Stroke Epidemiological Protocol RISK FACTORS IN ISCHEMIC STROKE PATIENTS WITH FABRY DISEASE AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL
More than one million people in Europe suffer from a stroke every day. Normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. Usually, these can only be explained for a minority by the classical risk factors such as diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke patients the etiology can be an undiagnosed genetic disease, e.g. Fabry disease. Fabry disease is a lysosomal storage disorder known to cause vasculopathy. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry disease and what risk factors might be able to predict this disease.
- Conditions
- Cerebrovascular Accident, Stroke, Acute, Cerebral Stroke
- Keywords
- Cerebrovascular Accident, Cerebrovascular Accident, Acute, Fabry Disease, Fabry´s Disease, Anderson-Fabry Disease, CVA (Cerebrovascular Accident), Stroke, Acute, Cerebral Stroke
- Medical subject headings
- Stroke, Fabry Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | all adult patients (18 - 60 years of age) with an acute cerebrovascular event of any etiology |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Arndt Rolfs, University of Rostock
- Investigators
- Arndt Rolfs, MD, Principal investigator, University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182818
- Sponsor's protocol ID
- FD01/2010
- Acronym
- FASEP
- Status last verified
- Jun 2012
- First submitted
- 16 Aug 2010
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FASEP Fabry and Stroke Epidemiological Protocol RISK FACTORS IN ISCHEMIC STROKE PATIENTS WITH FABRY DISEASE AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL
- ClinicalTrials.gov ID
- NCT01182818
- Acronym / sponsor ID
- FASEP / FD01/2010
- Conditions
- Cerebrovascular Accident, Stroke, Acute, Cerebral Stroke
- Keywords
- Cerebrovascular Accident, Cerebrovascular Accident, Acute, Fabry Disease, Fabry´s Disease, Anderson-Fabry Disease, CVA (Cerebrovascular Accident), Stroke, Acute, Cerebral Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Aug 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.
More than one million people in Europe suffer from a stroke every day. Normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. Usually, these can only be explained for a minority by the classical risk factors such as diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke patients the etiology can be an undiagnosed genetic disease, e.g. Fabry disease. Fabry disease is a lysosomal storage disorder known to cause vasculopathy. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry disease and what risk factors might be able to predict this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –all adult patients (18 - 60 years of age) with an acute cerebrovascular event of any etiology |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients with acute ischemic cerebrovascular event of any ischemic etiology
Key inclusion criteria (4 listed)
- Adult patients (18 - 60 years of age) with an acute ischemic cerebrovascular event either acute ischemic stroke or transient ischemic attack within 10 days
- Diagnosis of the cerebrovascular event (CVE) by a stroke experienced physician
- Diagnostic procedures for CVE according to the local guidelines and recommendations
- Written informed consent from patient or legal representative according to local regulations
Key exclusion criteria (5 listed)
- Patients being younger than 18 years or older than 60 years of age.
- Acute ischemic stroke or transient ischemic attack longer than 10 days before enrollment into the study
- CVE associated with intracranial hemorrhage as evidenced by cerebral CT scan
- Any uncertainty in the diagnosis
- No written informed consent from the patient or legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Jun 2012.
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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.
Arndt Rolfs, MD principal investigator
University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Stroke, Acute, run by University of Rostock at 14 sites in 2 countries.
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 4 inclusion and 5 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Poland. 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.
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 14 Jun 2012.