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Sponsors and Collaborators: |
University of Rostock Shire Human Genetic Therapies, Inc. |
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Information provided by: | University of Rostock |
ClinicalTrials.gov Identifier: | NCT00414583 |
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.
Condition | Intervention |
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Cerebrovascular Accident |
Other: No intervention |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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 |
Fabry diagnostic will be done centrally: blood samples will be retained for analysis of a-galactosidase in blood to diagnose an a-galactosidase deficit; in females direct analysis of the gene has to be done since due to the Lyonisation effect a-galactosidase activity might be normal in blood although the patient might suffer from Fabry disease.
Estimated Enrollment: | 5000 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Observation
all adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology
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Other: No intervention
Observational study, only laboratory analysis and diagnostic interventions done; no drug tested
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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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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 enrolment into the study
Inclusion Criteria:
Exclusion Criteria:
Contact: Arndt Rolfs, Prof., MD | +49-381-494- ext -9540 | arndt.rolfs@med.uni-rostock.de |
Contact: Sabine Rösner | +49-381-494- ext -4797 | sabine.roesner@med.uni-rostock.de |
Principal Investigator: | Arndt Rolfs, Prof., MD | University of Rostock, Department of Neurology |
Responsible Party: | University of Rostock ( Prof. Dr. med. Arndt Rolfs ) |
Study ID Numbers: | II PV 03/2006 |
Study First Received: | December 19, 2006 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00414583 |
Health Authority: | Germany: Ethics Commission; France: Institutional Ethical Committee |
Cerebrovascular Accident Cerebrovascular Accident, Acute CVA (Cerebrovascular Accident) Cerebral Stroke Stroke, Acute |
Cerebrovascular Stroke Fabry Disease Anderson-Fabry Disease Fabry's Disease |
Lipid Metabolism, Inborn Errors Sphingolipidoses Cerebral Infarction Brain Diseases Cerebrovascular Disorders Metabolism, Inborn Errors Ceramide trihexosidosis Fabry Disease Genetic Diseases, X-Linked Brain Ischemia Brain Diseases, Metabolic, Inborn Metabolic Diseases Lysosomal Storage Diseases |
Stroke Vascular Diseases Fabry disease Central Nervous System Diseases Sphingolipidosis Ischemia Genetic Diseases, Inborn Lipidoses Brain Infarction Metabolic disorder Infarction Brain Diseases, Metabolic Lipid Metabolism Disorders |
Lysosomal Storage Diseases, Nervous System Nervous System Diseases Cardiovascular Diseases |