Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
This study has been completed.
Sponsor:
University of Rostock
Information provided by (Responsible Party):
Prof. Dr. Arndt Rolfs, University of Rostock
ClinicalTrials.gov Identifier:
NCT01182818
First received: August 16, 2010
Last updated: June 13, 2012
Last verified: June 2012
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Purpose
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.
| Condition |
|---|
|
Cerebrovascular Accident Stroke, Acute Cerebral Stroke |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | FASEP Fabry and Stroke Epidemiological Protocol RISK FACTORS IN ISCHEMIC STROKE PATIENTS WITH FABRY DISEASE AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Fabry disease
Farber lipogranulomatosis
Schindler disease
succinic semialdehyde dehydrogenase deficiency
U.S. FDA Resources
Further study details as provided by University of Rostock:
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.
| Enrollment: | 1000 |
| Study Start Date: | September 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Observation
all adult patients (18 - 60 years of age) with an acute cerebrovascular event of any etiology
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Adult patients with acute ischemic cerebrovascular event of any ischemic etiology
Criteria
Inclusion Criteria:
- Adult patients (18 - 60 years of age) with an acute ischemic cerebrovascular event either acute ischemic stroke or transient ischemic attack within 10 days
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182818
Locations
| Germany | |
| Department of Neurology, Kreiskrankenhaus Altenburg | |
| Altenburg, Germany, 04600 | |
| Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln | |
| Berlin, Germany, 12351 | |
| Department of Neurology, Allgemeines Krankenhaus Celle | |
| Celle, Germany, 29223 | |
| Department of Neurology, Klinikum Chemnitz gGmbH | |
| Chemnitz, Germany, 09131 | |
| Heinrich-Heine University Duesseldorf, Dept. of Neurology | |
| Duesseldorf, Germany, D-40225 | |
| Universitätsklinikum Giessen, Department of Neurology | |
| Giessen, Germany, 35392 | |
| Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf | |
| Hamburg, Germany, 20246 | |
| Universität Heidelberg, Klinik für Neurologie | |
| Heidelberg, Germany, 69120 | |
| Department of Neurology, Universitaetsklinikum Jena | |
| Jena, Germany, 07740 | |
| Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH | |
| Mühlhausen / Thürigen, Germany, 99974 | |
| Universitätsklinikum Regensburg, Klinik für Neurologie | |
| Regensburg, Germany, 93053 | |
| University of Rostock, Department of Neurology | |
| Rostock, Germany, D-18055 | |
| University of Ulm, Department of Neurology | |
| Ulm, Germany, D-89081 | |
| Poland | |
| Institute of Psychiatry and Neurology, Dept. of Neurology | |
| Warsaw, Poland, 02-957 | |
Sponsors and Collaborators
University of Rostock
Investigators
| Principal Investigator: | Arndt Rolfs, MD | University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration |
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof. Dr. Arndt Rolfs, Prof. Dr. med., University of Rostock |
| ClinicalTrials.gov Identifier: | NCT01182818 History of Changes |
| Other Study ID Numbers: | FD01/2010 |
| Study First Received: | August 16, 2010 |
| Last Updated: | June 13, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Rostock:
|
Cerebrovascular Accident Cerebrovascular Accident, Acute Fabry Disease Fabry´s Disease |
Anderson-Fabry Disease CVA (Cerebrovascular Accident) Stroke, Acute Cerebral Stroke |
Additional relevant MeSH terms:
|
Fabry Disease Cerebral Infarction Stroke Sphingolipidoses Lysosomal Storage Diseases, Nervous System Brain Diseases, Metabolic, Inborn Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn |
Metabolism, Inborn Errors Lipidoses Lipid Metabolism, Inborn Errors Lysosomal Storage Diseases Metabolic Diseases Lipid Metabolism Disorders Brain Infarction Brain Ischemia Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013