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

Completed

• Conditions: Cerebrovascular Accident

• 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.

Study Timeline

• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-21
• Study Start: 2008-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2020-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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)

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, 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

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