Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01182818
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2010-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Belgium', 'Croatia', 'France', 'Portugal', 'Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000795', 'term': 'Fabry Disease'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013106', 'term': 'Sphingolipidoses'}, {'id': 'D020140', 'term': 'Lysosomal Storage Diseases, Nervous System'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008064', 'term': 'Lipidoses'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-13', 'studyFirstSubmitDate': '2010-08-16', 'studyFirstSubmitQcDate': '2010-08-16', 'lastUpdatePostDateStruct': {'date': '2012-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cerebrovascular Accident', 'Cerebrovascular Accident, Acute', 'Fabry Disease', 'Fabry´s Disease', 'Anderson-Fabry Disease', 'CVA (Cerebrovascular Accident)', 'Stroke, Acute', 'Cerebral Stroke'], 'conditions': ['Cerebrovascular Accident', 'Stroke, Acute', 'Cerebral Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fasep.eu', 'label': 'study homepage'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with acute ischemic cerebrovascular event of any ischemic etiology', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 - 60 years of age) with an acute ischemic cerebrovascular event either acute ischemic stroke or transient ischemic attack within 10 days\n* Diagnosis of the cerebrovascular event (CVE) by a stroke experienced physician\n* Diagnostic procedures for CVE according to the local guidelines and recommendations\n* Written informed consent from patient or legal representative according to local regulations\n\nExclusion Criteria:\n\n* Patients being younger than 18 years or older than 60 years of age.\n* Acute ischemic stroke or transient ischemic attack longer than 10 days before enrollment into the study\n* CVE associated with intracranial hemorrhage as evidenced by cerebral CT scan\n* Any uncertainty in the diagnosis\n* No written informed consent from the patient or legal representative'}, 'identificationModule': {'nctId': 'NCT01182818', 'acronym': 'FASEP', 'briefTitle': 'Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Rostock'}, 'officialTitle': 'FASEP Fabry and Stroke Epidemiological Protocol RISK FACTORS IN ISCHEMIC STROKE PATIENTS WITH FABRY DISEASE AN INTERNATIONAL, MULTICENTER, EPIDEMIOLOGICAL PROTOCOL', 'orgStudyIdInfo': {'id': 'FD01/2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation', 'description': 'all adult patients (18 - 60 years of age) with an acute cerebrovascular event of any etiology'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04600', 'city': 'Altenburg', 'country': 'Germany', 'facility': 'Department of Neurology, Kreiskrankenhaus Altenburg', 'geoPoint': {'lat': 50.98763, 'lon': 12.43684}}, {'zip': '12351', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '29223', 'city': 'Celle', 'country': 'Germany', 'facility': 'Department of Neurology, Allgemeines Krankenhaus Celle', 'geoPoint': {'lat': 52.62264, 'lon': 10.08047}}, {'zip': '09131', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Department of Neurology, Klinikum Chemnitz gGmbH', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': 'D-40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Heinrich-Heine University Duesseldorf, Dept. of Neurology', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitätsklinikum Giessen, Department of Neurology', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universität Heidelberg, Klinik für Neurologie', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '07740', 'city': 'Jena', 'country': 'Germany', 'facility': 'Department of Neurology, Universitaetsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '99974', 'city': 'Mühlhausen / Thürigen', 'country': 'Germany', 'facility': 'Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH'}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Regensburg, Klinik für Neurologie', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': 'D-18055', 'city': 'Rostock', 'country': 'Germany', 'facility': 'University of Rostock, Department of Neurology', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': 'D-89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'University of Ulm, Department of Neurology', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '02-957', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Institute of Psychiatry and Neurology, Dept. of Neurology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Arndt Rolfs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rostock, Albrecht-Kossel-Institute for Neuroregeneration'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rostock', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Prof. Dr. Arndt Rolfs', 'investigatorAffiliation': 'University of Rostock'}}}}