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

April 8, 2021 updated by: CENTOGENE GmbH Rostock

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • Universitätsklinikum für Neurologie
      • Innsbruck, Austria, 6020
        • Department of Neurology, Universitaetsklinik fuer Neurologie Innsbruck
      • Linz, Austria, A-4020
        • Wagner-Jauregg Linz, Department of Neurology
      • Salzburg, Austria, 5020
        • Christian-Doppler-Klinik, Department für medizin. Studien
      • Wien, Austria, 1020
        • Krankenhaus der Barmherzigen Brüder, Abteilung für Neurologie
  • Belgium
      • Antwerp, Belgium, 2020
        • Middelheim General Hospital, Dept. of Neurology/Memory Clinic
      • Leuven, Belgium, 3000
        • UZ Gasthuisburg Hospital
  • Croatia
      • Zagreb, Croatia, 10000
        • Department of Neurology, University Hospital Sestre Milosrdnice
  • Finland
      • Helsinki, Finland, 00290
        • Helsinki University Central Hospital, Department of Neurology
  • France
      • Lyon, France, F-69003
        • Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires
  • Georgia
      • Tblisi, Georgia, 0179
        • Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university
  • Germany
      • Altenburg, Germany, 04600
        • Department of Neurology, Kreiskrankenhaus Altenburg
      • Bayreuth, Germany, 95445
        • Department of Neurology, Klinikum Hohe Warte
      • Berlin, Germany, 12351
        • Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln
      • Berlin, Germany, D-12200
        • Charite Campus Benjamin Franklin, Dept. of Neurology
      • Bremen, Germany, 28177
        • Klinikum Bremen Mitte gGmbH, Neurologische Klinik
      • Celle, Germany, 29223
        • Department of Neurology, Allgemeines Krankenhaus Celle
      • Chemnitz, Germany, 09131
        • Department of Neurology, Klinikum Chemnitz gGmbH
      • Dresden, Germany, 01307
        • Department of Neurology, Universitaetsklinikum Carl Gustav Carus
      • Duesseldorf, Germany, D-40225
        • Heinrich-Heine University Duesseldorf, Dept. of Neurology
      • Frankfurt, Germany, 60528
        • Dept. of Neurology, Johann-Wolfgang-Goethe-Universität
      • Giessen, Germany, D-35385
        • University of Giessen-Marburg Dept. of Neurology
      • Greifswald, Germany, 17489
        • Department of Neurology, Ernst-Moritz-Arndt-University
      • Halle (Saale), Germany, 06120
        • Dept. of Neurology, Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie
      • Hamburg, Germany, 20246
        • Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany, D-69120
        • University of Heidelberg, Department of Neurology
      • Jena, Germany, 07740
        • Department of Neurology, Universitaetsklinikum Jena
      • Kiel, Germany, D-24105
        • University Schleswig-Holstein, Dept. of Neurology
      • Leipzig, Germany, 04103
        • Department of Neurology, Universitaetsklinikum Leipzig
      • Marburg, Germany, 35039
        • Department of Neurology, Universitaetsklinikum Giessen und Marburg GmbH
      • Muenster, Germany, D-48149
        • University of Muenster, Dept. of Neurology
      • Mühlhausen, Germany, 99974
        • Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH
      • München, Germany, D-81377
        • Ludwig-Maximilians-University of Munich, Dept. of Neurology
      • Regensburg, Germany, 93053
        • Department of Neurology, Klinik und Poliklinik fuer Neurologie
      • Rostock, Germany, D-18055
        • University of Rostock, Department of Neurology
      • Tuebingen, Germany, 72076
        • Department of Neurology, University Tuebingen
      • Ulm, Germany, D-89081
        • University of Ulm, Department of Neurology
  • Ireland
      • Dublin, Ireland, 24
        • The Adelaide and Meath Hospital, Department of Neurology
  • Italy
      • Milan, Italy, 20122
        • Dept. of Neurology, Ospoedale Maggiore Policlinico
  • Malta
      • Msida, Malta
        • Neuromedical Ward, Mater Dei Hospital
  • Poland
      • Warsaw, Poland, 02-957
        • Institute of Psychiatry and Neurology, Dept. of Neurology
  • Portugal
      • Lisboa, Portugal, 1150-199
        • Centro Hospitalar de Lisboa Central, Servico de Neurologia
  • Spain
      • Madrid, Spain, 28046
        • Department of Neurology, Hospital Universitario La Paz
  • United Kingdom
      • Oxford, United Kingdom, OX39DU
        • Stroke Prevention Research Unit, John Radcliffe Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Stroke Prevention Research Unit, Dept. of Clinical Neurology, University of Glasgow, Southern General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observation
all adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology
Other: No intervention
Observational study, only laboratory analysis and diagnostic interventions done; no drug tested
Other Names:
  • only 1 observational group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Fabry disease in the unselected group of young stroke patients
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Classification of stroke subtype in patients identified to have Fabry disease acc. to TOAST criteria, modified Rankin scale, Barthel index and MRI criteria.
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CENTOGENE GmbH Rostock

Collaborators

Shire Human Genetic Therapies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 19, 2006

First Posted (Estimate)

December 21, 2006

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • II PV03/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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