Stroke, Acute Clinical Trial
— FASEPOfficial title:
FASEP Fabry and Stroke Epidemiological Protocol RISK FACTORS IN ISCHEMIC STROKE PATIENTS WITH FABRY DISEASE AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL
Verified date | June 2012 |
Source | University of Rostock |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1000 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Department of Neurology, Kreiskrankenhaus Altenburg | Altenburg | |
Germany | Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln | Berlin | |
Germany | Department of Neurology, Allgemeines Krankenhaus Celle | Celle | |
Germany | Department of Neurology, Klinikum Chemnitz gGmbH | Chemnitz | |
Germany | Heinrich-Heine University Duesseldorf, Dept. of Neurology | Duesseldorf | |
Germany | Universitätsklinikum Giessen, Department of Neurology | Giessen | |
Germany | Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Universität Heidelberg, Klinik für Neurologie | Heidelberg | |
Germany | Department of Neurology, Universitaetsklinikum Jena | Jena | |
Germany | Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH | Mühlhausen / Thürigen | |
Germany | Universitätsklinikum Regensburg, Klinik für Neurologie | Regensburg | |
Germany | University of Rostock, Department of Neurology | Rostock | |
Germany | University of Ulm, Department of Neurology | Ulm | |
Poland | Institute of Psychiatry and Neurology, Dept. of Neurology | Warsaw |
Lead Sponsor | Collaborator |
---|---|
University of Rostock |
Germany, Poland,
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