Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in Young Stroke Patients
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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 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 |
|---|---|
|
Cerebrovascular Accident |
Other: No intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: 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 |
- Prevalence of Fabry disease in the unselected group of young stroke patients [ Time Frame: baseline ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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.
| Enrollment: | 5000 |
| Study Start Date: | January 2008 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 Name: only 1 observational group
|
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.
Eligibility| 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 enrollment into the study
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
Contacts and Locations
Show 45 Study Locations| Principal Investigator: | Arndt Rolfs, Prof., MD | University of Rostock, Department of Neurology |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof. Dr. med. Arndt Rolfs, University of Rostock |
| ClinicalTrials.gov Identifier: | NCT00414583 History of Changes |
| Other Study ID Numbers: | II PV03/2006 |
| Study First Received: | December 19, 2006 |
| Last Updated: | October 10, 2012 |
| Health Authority: | Germany: Ethics Commission France: Institutional Ethical Committee |
Keywords provided by University of Rostock:
|
Cerebrovascular Accident Cerebrovascular Accident, Acute CVA (Cerebrovascular Accident) Cerebral Stroke Stroke, Acute |
Cerebrovascular Stroke Fabry Disease Anderson-Fabry Disease Fabry's Disease |
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 June 17, 2013