Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00268034
Status:
TERMINATED
Last Update Posted:
2007-05-07
First Post:
2005-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Ventricular Aneurysms in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 5}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-03', 'studyFirstSubmitDate': '2005-12-20', 'studyFirstSubmitQcDate': '2005-12-20', 'lastUpdatePostDateStruct': {'date': '2007-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['pediatric', 'cardiac', 'aneurysms', 'left ventricular aneurysms', 'surgical repair for LV aneurysms'], 'conditions': ['Congenital Disorders']}, 'descriptionModule': {'briefSummary': 'Collect data to support "standard of care possibility" of extracardiac repair with closure of intracavitary communication and plication of the aneurysm as probably safest surgical repair for left ventricular aneurysms.', 'detailedDescription': 'Ventricular aneurysms in the pediatric population are rare and no standardized method of treatment exists.\n\nWe plan on reviewing five patient charts between the dates of 6.30.02 and 6.30.04 as to causes of aneurysms. The patient charts selected will be in the following "aneurysm categories":\n\nMostly occur after:\n\nRoss/Ross-Konno procedures modified Rastelli-type interventricular tunnels repeated resections of subaortic stenosis and possibly after: myocardial ischemia trauma drainage of abscess in infective endocarditis progressive herniation of endocardium mostly located: in LV outflow tract\n\nWe plan on collecting echocardiograms and / or cardiac catheterizations data in order to confirm the diagnosis of an aneurysm. We will also collect the following information:\n\n* Procedures including the dates performed\n* Medications\n* Physical Exam Findings\n* Weight\n* Gestational Age\n* Outcome'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aneurysms between 6.30.2002 and 6.30.2004\n\nExclusion Criteria:\n\n* those children who do no meet inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00268034', 'briefTitle': 'Left Ventricular Aneurysms in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'Left Ventricular Aneurysms in Children', 'orgStudyIdInfo': {'id': '04-073'}}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Kirk R Kanter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Healthcare of Atlanta"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}}}}