Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in Young Stroke Patients

NCT ID: NCT00414583

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-01-31

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.

Conditions

Cerebrovascular Accident

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation

all adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology

No intervention

Intervention Type: OTHER

Observational study, only laboratory analysis and diagnostic interventions done; no drug tested

Interventions

No intervention

Observational study, only laboratory analysis and diagnostic interventions done; no drug tested

Intervention Type: OTHER

Other Intervention Names

only 1 observational group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire Human Genetic Therapies, Inc.

INDUSTRY

Sponsor Role: collaborator

CENTOGENE GmbH Rostock

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum für Neurologie

Graz, , Austria

Department of Neurology, Universitaetsklinik fuer Neurologie Innsbruck

Innsbruck, , Austria

Wagner-Jauregg Linz, Department of Neurology

Linz, , Austria

Christian-Doppler-Klinik, Department für medizin. Studien

Salzburg, , Austria

Krankenhaus der Barmherzigen Brüder, Abteilung für Neurologie

Vienna, , Austria

Middelheim General Hospital, Dept. of Neurology/Memory Clinic

Antwerp, , Belgium

UZ Gasthuisburg Hospital

Leuven, , Belgium

Department of Neurology, University Hospital Sestre Milosrdnice

Zagreb, , Croatia

Helsinki University Central Hospital, Department of Neurology

Helsinki, , Finland

Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires

Lyon, , France

Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university

Tbilisi, , Georgia

Department of Neurology, Kreiskrankenhaus Altenburg

Altenburg, , Germany

Department of Neurology, Klinikum Hohe Warte

Bayreuth, , Germany

Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln

Berlin, , Germany

Charite Campus Benjamin Franklin, Dept. of Neurology

Berlin, , Germany

Klinikum Bremen Mitte gGmbH, Neurologische Klinik

Bremen, , Germany

Department of Neurology, Allgemeines Krankenhaus Celle

Celle, , Germany

Department of Neurology, Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Department of Neurology, Universitaetsklinikum Carl Gustav Carus

Dresden, , Germany

Heinrich-Heine University Duesseldorf, Dept. of Neurology

Düsseldorf, , Germany

Dept. of Neurology, Johann-Wolfgang-Goethe-Universität

Frankfurt, , Germany

University of Giessen-Marburg Dept. of Neurology

Giessen, , Germany

Department of Neurology, Ernst-Moritz-Arndt-University

Greifswald, , Germany

Dept. of Neurology, Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie

Halle, , Germany

Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

University of Heidelberg, Department of Neurology

Heidelberg, , Germany

Department of Neurology, Universitaetsklinikum Jena

Jena, , Germany

University Schleswig-Holstein, Dept. of Neurology

Kiel, , Germany

Department of Neurology, Universitaetsklinikum Leipzig

Leipzig, , Germany

Department of Neurology, Universitaetsklinikum Giessen und Marburg GmbH

Marburg, , Germany

Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH

Mühlhausen, , Germany

Ludwig-Maximilians-University of Munich, Dept. of Neurology

München, , Germany

University of Muenster, Dept. of Neurology

Münster, , Germany

Department of Neurology, Klinik und Poliklinik fuer Neurologie

Regensburg, , Germany

University of Rostock, Department of Neurology

Rostock, , Germany

Department of Neurology, University Tuebingen

Tübingen, , 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

Neuromedical Ward, Mater Dei Hospital

Msida, , Malta

Institute of Psychiatry and Neurology, Dept. of Neurology

Warsaw, , Poland

Centro Hospitalar de Lisboa Central, Servico de Neurologia

Lisbon, , Portugal

Department of Neurology, Hospital Universitario La Paz

Madrid, , Spain

Stroke Prevention Research Unit, Dept. of Clinical Neurology, University of Glasgow, Southern General Hospital

Glasgow, Scotland, United Kingdom

Stroke Prevention Research Unit, John Radcliffe Hospital

Oxford, , United Kingdom

Countries

Austria; Belgium; Croatia; Finland; France; Georgia; Germany; Ireland; Italy; Malta; Poland; Portugal; Spain; United Kingdom

References

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Reference Type: BACKGROUND

PMID: 16298216 (View on PubMed)

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Other Identifiers

II PV03/2006

Identifier Type: -

Identifier Source: org_study_id