Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT03099967
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TnT changes', 'timeFrame': 'Blood samples for TnT were taken one day before intervention and one day after intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'To examine retrospectively whether transcatheter closure of the interatrial septum leads to myocardial injury and to determine the mechanism.', 'detailedDescription': 'In a prospective study in adults troponin T (TnT) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (ASD) or patent foramen ovale (PFO).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fifty one patients who underwent transcatheter ASD and PFO closure (the University Hospital of Lund, Sweden) were studied retrospectively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* transcatheter ASD and PFO closure at the University Hospital of Lund, Sweden\n\nExclusion Criteria:\n\n* missing TnT values'}, 'identificationModule': {'nctId': 'NCT03099967', 'briefTitle': 'Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum', 'orgStudyIdInfo': {'id': 'Interatrial septum 1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcatheter closure of an atrial septal defect or patent foramen ovale.', 'type': 'DEVICE', 'description': 'In a prospective study in adults troponin T (TnT) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (ASD) or patent foramen ovale (PFO).'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associated Professor', 'investigatorFullName': 'Joanna Hlebowicz', 'investigatorAffiliation': 'Skane University Hospital'}}}}