Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
FASEP
FASEP Fabry and Stroke Epidemiological Protocol RISK FACTORS IN ISCHEMIC STROKE PATIENTS WITH FABRY DISEASE AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL
This date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)
Study Completion
April 2012
Actual (reported)
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 can only be explained for a minority 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 etiology can be an undiagnosed genetic disease, e.g. Fabry disease. Fabry disease is a lysosomal storage disorder known to cause vasculopathy. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry disease and what risk factors might be able to predict this disease.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
1,000 participants
Study completion date
April 2012
Actual (reported)
Listed locations
2 countries · 14 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
August 16, 2010
Actual (reported)
First Posted
August 17, 2010
Actual (reported)
Study Start
September 2010
Date type not reported
This date has not been verified as actual or estimated.
all adult patients (18 - 60 years of age) with an acute cerebrovascular event of any etiology
Eligibility Criteria
Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population
Adult patients with acute ischemic cerebrovascular event of any ischemic etiology
You may qualify if:
Adult patients (18 - 60 years of age) with an acute ischemic cerebrovascular event either acute ischemic stroke or transient ischemic attack within 10 days
Department of Neurology, Kreiskrankenhaus Altenburg
Altenburg, 04600, Germany
Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln
Berlin, 12351, Germany
Department of Neurology, Allgemeines Krankenhaus Celle
Celle, 29223, Germany
Department of Neurology, Klinikum Chemnitz gGmbH
Chemnitz, 09131, Germany
Heinrich-Heine University Duesseldorf, Dept. of Neurology
Düsseldorf, D-40225, Germany
Universitätsklinikum Giessen, Department of Neurology
Giessen, 35392, Germany
Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf
Biospecimen
Retention: SAMPLES WITH DNA
Fabry diagnostic will be done centrally: blood samples will be stored for analysis of a-galactosidase in blood, Gb3 as well as lyso-Gb3. In all cases direct analysis of the gene will be done, especially in females where due to the Lyonisation effect a-galactosidase activity might be normal in blood although the patient might suffer from Fabry disease.
MeSH Terms
Conditions
StrokeFabry Disease
Condition Hierarchy (Ancestors)
Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicCerebral Small Vessel DiseasesGenetic Diseases, X-LinkedGenetic Diseases, Inborn
Study Officials
Arndt Rolfs, MD
University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration
PRINCIPAL INVESTIGATOR
Enrollment
1,000 participants (actual enrollment reported by the registry).
Study Design
Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.
Study Record Dates
First Submitted
August 16, 2010
First Posted
August 17, 2010
Study Start
September 2010
Date type not reported
This date has not been verified as actual or estimated.
Diagnosis of the cerebrovascular event (CVE) by a stroke experienced physician
Diagnostic procedures for CVE according to the local guidelines and recommendations
Written informed consent from patient or legal representative according to local regulations
You may not qualify if:
Patients being younger than 18 years or older than 60 years of age.
Acute ischemic stroke or transient ischemic attack longer than 10 days before enrollment into the study
CVE associated with intracranial hemorrhage as evidenced by cerebral CT scan
Any uncertainty in the diagnosis
No written informed consent from the patient or legal representative
Contact the study team to confirm eligibility.
Hamburg, 20246, Germany
Universität Heidelberg, Klinik für Neurologie
Heidelberg, 69120, Germany
Department of Neurology, Universitaetsklinikum Jena
Jena, 07740, Germany
Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH
Mühlhausen / Thürigen, 99974, Germany
Universitätsklinikum Regensburg, Klinik für Neurologie
Regensburg, 93053, Germany
University of Rostock, Department of Neurology
Rostock, D-18055, Germany
University of Ulm, Department of Neurology
Ulm, D-89081, Germany
Institute of Psychiatry and Neurology, Dept. of Neurology
Warsaw, 02-957, Poland
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Nutritional and Metabolic Diseases
Lipid Metabolism Disorders
Primary Completion
April 2012
Actual (reported)
Study Completion
April 2012
Actual (reported)
Last Updated
June 14, 2012
Record last verified: 2012-06
Source record
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Source: ClinicalTrials.gov.
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