Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in Young Stroke Patients
- Conditions
- Cerebrovascular Accident
- Interventions
- Other: No intervention
- Registration Number
- NCT00414583
- Lead Sponsor
- CENTOGENE GmbH Rostock
- Brief 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 cannot be explained 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 cause could have been an undiagnosed genetic disease, the so called Fabry disease. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry Disease.
- Detailed Description
Aim:
To determine the frequency of Fabry disease in an unselected group of young patients (18 - 55 years of age) with acute cerebrovascular event (CVE)
Fabry disease and stroke:
Rolfs and co-workers have shown a high frequency of Fabry disease in a cohort of patients with cryptogenic stroke (4 % \[28/721\]) aged between 18 and 55 years. This corresponds to about 1.2 % in the general population of young stroke patients. Therefore the authors stated that Fabry disease must be considered in all cases of unexplained stroke in young patients, especially in cases with the combination of infarction in the vertebrobasilar artery system and proteinuria.
Cryptogenic strokes are cerebrovascular lesions of unknown origin. Clinical and laboratory data show that Fabry disease is itself a risk factor for accelerated atherosclerosis and cardiac and renal disease, which can lead to emboli and hypertension. The pilot-phase started April 2007; the official study started January 2008.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5000
- Adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology defined as patients having an acute ischemic stroke or transient ischemic attack less than 3 months before enrollment into the study
- MRI-scan evidence of associated corresponding brain infarction or hemorrhage, regardless of the duration of symptoms. Alternatively also patients with no signs of stroke in the MRI can be included if a stroke-experienced neurologist has done the initial diagnosis as ischemic stroke, transient ischemic attack or hemorrhage.
- Detailed MRI documentation at admission to entry to the study
- Diagnostic procedures for CVE according to the EUSI recommendations
- Written informed consent from patient or legal representative according to local regulations
- Patients being younger than 18 years or older than 55 years of age.
- Acute ischemic stroke or transient ischemic attack longer than 3 months before enrolment into the study
- Diagnosis of the CVE within the last 3 months has been done by a non-neurologist if there is no MRI-scan evidence of associated brain infarction or hemorrhage
- No detailed MRI documentation at admission to entry to the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observation No intervention all adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology
- Primary Outcome Measures
Name Time Method Prevalence of Fabry disease in the unselected group of young stroke patients baseline
- Secondary Outcome Measures
Name Time Method Classification of stroke subtype in patients identified to have Fabry disease acc. to TOAST criteria, modified Rankin scale, Barthel index and MRI criteria. baseline
Trial Locations
- Locations (45)
Christian-Doppler-Klinik, Department für medizin. Studien
🇦🇹Salzburg, Austria
Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university
🇬🇪Tblisi, Georgia
Department of Neurology, Kreiskrankenhaus Altenburg
🇩🇪Altenburg, Germany
Charite Campus Benjamin Franklin, Dept. of Neurology
🇩🇪Berlin, Germany
Department of Neurology, Universitaetsklinik fuer Neurologie Innsbruck
🇦🇹Innsbruck, Austria
Wagner-Jauregg Linz, Department of Neurology
🇦🇹Linz, Austria
Department of Neurology, Klinikum Hohe Warte
🇩🇪Bayreuth, Germany
Department of Neurology, Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Middelheim General Hospital, Dept. of Neurology/Memory Clinic
🇧🇪Antwerp, Belgium
Heinrich-Heine University Duesseldorf, Dept. of Neurology
🇩🇪Duesseldorf, Germany
Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Department of Neurology, Ernst-Moritz-Arndt-University
🇩🇪Greifswald, Germany
Krankenhaus der Barmherzigen Brüder, Abteilung für Neurologie
🇦🇹Wien, Austria
Helsinki University Central Hospital, Department of Neurology
🇫🇮Helsinki, Finland
Dept. of Neurology, Johann-Wolfgang-Goethe-Universität
🇩🇪Frankfurt, Germany
Department of Neurology, Universitaetsklinikum Giessen und Marburg GmbH
🇩🇪Marburg, Germany
Department of Neurology, University Tuebingen
🇩🇪Tuebingen, Germany
University of Ulm, Department of Neurology
🇩🇪Ulm, Germany
The Adelaide and Meath Hospital, Department of Neurology
🇮🇪Dublin, Ireland
Dept. of Neurology, Ospoedale Maggiore Policlinico
🇮🇹Milan, Italy
Department of Neurology, Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires
🇫🇷Lyon, France
Universitätsklinikum für Neurologie
🇦🇹Graz, Austria
UZ Gasthuisburg Hospital
🇧🇪Leuven, Belgium
Department of Neurology, University Hospital Sestre Milosrdnice
ðŸ‡ðŸ‡·Zagreb, Croatia
Klinikum Bremen Mitte gGmbH, Neurologische Klinik
🇩🇪Bremen, Germany
Department of Neurology, Allgemeines Krankenhaus Celle
🇩🇪Celle, Germany
Department of Neurology, Universitaetsklinikum Jena
🇩🇪Jena, Germany
University Schleswig-Holstein, Dept. of Neurology
🇩🇪Kiel, Germany
University of Muenster, Dept. of Neurology
🇩🇪Muenster, Germany
Department of Neurology, Klinik und Poliklinik fuer Neurologie
🇩🇪Regensburg, Germany
Institute of Psychiatry and Neurology, Dept. of Neurology
🇵🇱Warsaw, Poland
Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln
🇩🇪Berlin, Germany
University of Rostock, Department of Neurology
🇩🇪Rostock, Germany
Department of Neurology, Universitaetsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
University of Giessen-Marburg Dept. of Neurology
🇩🇪Giessen, Germany
Dept. of Neurology, Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie
🇩🇪Halle (Saale), Germany
Neuromedical Ward, Mater Dei Hospital
🇲🇹Msida, Malta
University of Heidelberg, Department of Neurology
🇩🇪Heidelberg, Germany
Department of Neurology, Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH
🇩🇪Mühlhausen, Germany
Ludwig-Maximilians-University of Munich, Dept. of Neurology
🇩🇪München, Germany
Centro Hospitalar de Lisboa Central, Servico de Neurologia
🇵🇹Lisboa, Portugal
Stroke Prevention Research Unit, John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Stroke Prevention Research Unit, Dept. of Clinical Neurology, University of Glasgow, Southern General Hospital
🇬🇧Glasgow, Scotland, United Kingdom