Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT01179451
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2010-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-19', 'studyFirstSubmitDate': '2010-08-10', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac valve function', 'timeFrame': 'at least 1 year after termination of antibiotic treatment'}]}, 'conditionsModule': {'conditions': ['Post Streptococcal Reactive Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether there is late cardial involvement in children diagnosed with post streptococcal reactive arthritis after discontinuation of prophylactic antibiotic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'out patient rheumatology clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PSRA patients under 18 who were diagnosed at least one year prior to the study\n\nExclusion Criteria:\n\n* PSRA patients under 18 who were diagnosed less one year prior to the study\n* patients who do not fulfill PSRA criteria\n* patients who fulfill Jones criteria\n* patients with a known heart defect'}, 'identificationModule': {'nctId': 'NCT01179451', 'briefTitle': 'Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study', 'orgStudyIdInfo': {'id': 'MMC10040-10CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post streptococcal reactive arthritis (PSRA)', 'description': 'children who were diagnosed with psra at least one year before the study', 'interventionNames': ['Device: echocardiogram']}], 'interventions': [{'name': 'echocardiogram', 'type': 'DEVICE', 'description': 'echocardiogram', 'armGroupLabels': ['Post streptococcal reactive arthritis (PSRA)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir medical center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}