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

Cerebrovascular Accident Clinical Trial

— sifap1  

Official title:

Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in an Unselected Group of Young Stroke Patients: an International, Multicentre Prevalence Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414583
• Other study ID #: II PV03/2006
• Status: Completed
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: April 2020
• Source: CENTOGENE GmbH Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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 information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Fabry Disease
• Stroke

Intervention

Other:
• No intervention
Observational study, only laboratory analysis and diagnostic interventions done; no drug tested

Locations

Country	Name	City	State
Austria	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	Wien
Belgium	Middelheim General Hospital, Dept. of Neurology/Memory Clinic	Antwerp
Belgium	UZ Gasthuisburg Hospital	Leuven
Croatia	Department of Neurology, University Hospital Sestre Milosrdnice	Zagreb
Finland	Helsinki University Central Hospital, Department of Neurology	Helsinki
France	Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires	Lyon
Georgia	Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university	Tblisi
Germany	Department of Neurology, Kreiskrankenhaus Altenburg	Altenburg
Germany	Department of Neurology, Klinikum Hohe Warte	Bayreuth
Germany	Charite Campus Benjamin Franklin, Dept. of Neurology	Berlin
Germany	Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln	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	Duesseldorf
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 (Saale)
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	University of Muenster, Dept. of Neurology	Muenster
Germany	Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH	Mühlhausen
Germany	Ludwig-Maximilians-University of Munich, Dept. of Neurology	München
Germany	Department of Neurology, Klinik und Poliklinik fuer Neurologie	Regensburg
Germany	University of Rostock, Department of Neurology	Rostock
Germany	Department of Neurology, University Tuebingen	Tuebingen
Germany	University of Ulm, Department of Neurology	Ulm
Ireland	The Adelaide and Meath Hospital, Department of Neurology	Dublin
Italy	Dept. of Neurology, Ospoedale Maggiore Policlinico	Milan
Malta	Neuromedical Ward, Mater Dei Hospital	Msida
Poland	Institute of Psychiatry and Neurology, Dept. of Neurology	Warsaw
Portugal	Centro Hospitalar de Lisboa Central, Servico de Neurologia	Lisboa
Spain	Department of Neurology, Hospital Universitario La Paz	Madrid
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
CENTOGENE GmbH Rostock	Shire Human Genetic Therapies, Inc.

Countries where clinical trial is conducted

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

References & Publications (2)

Rolfs A, Böttcher T, Zschiesche M, Morris P, Winchester B, Bauer P, Walter U, Mix E, Löhr M, Harzer K, Strauss U, Pahnke J, Grossmann A, Benecke R. Prevalence of Fabry disease in patients with cryptogenic stroke: a prospective study. Lancet. 2005 Nov 19;366(9499):1794-6. Erratum in: Lancet. 2006 Dec 23;368(9554):2210. — View Citation

Rolfs A, Martus P, Heuschmann PU, Grittner U, Holzhausen M, Tatlisumak T, Böttcher T, Fazekas F, Enzinger C, Ropele S, Schmidt R, Riess O, Norrving B; sifap1 Investigators. Protocol and methodology of the Stroke in Young Fabry Patients (sifap1) study: a prospective multicenter European study of 5,024 young stroke patients aged 18-55 years. Cerebrovasc Dis. 2011;31(3):253-62. doi: 10.1159/000322153. Epub 2010 Dec 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Fabry disease in the unselected group of young stroke patients		baseline
Secondary	Classification of stroke subtype in patients identified to have Fabry disease acc. to TOAST criteria, modified Rankin scale, Barthel index and MRI criteria.		baseline

External Links

•   study homepage