Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-11 @ 12:22 PM
Study NCT ID:
NCT02388893
Status:
UNKNOWN
Last Update Posted:
2018-10-17
First Post:
2015-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endocarditis Registry of the University Hospital of Cologne (ER-UHC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004696', 'term': 'Endocarditis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2015-03-13', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '1 year', 'description': '1-year all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Inhospital all-cause mortality', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infective Endocarditis']}, 'descriptionModule': {'briefSummary': 'As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team including an cardiologist, infectious disease specialist, and cardiac surgeon. Our registry is a prospective, national registry of patients with IE. From January 2013 data from endocarditis board were prospectively recorded using standard definitions during the hospitalization. Patient demographics, clinical, laboratory, and imaging data at the time of IE diagnosis, as well as treatment outcomes were entered into the ER-UHC database.', 'detailedDescription': 'The primary endpoint will be the 1 year all-cause mortality after treatment begins of IE. We will use 1 year all-cause mortality as the primary endpoint because it has been demonstrated that a period of at least 6 months is necessary to offset the early postoperative mortality related to valve surgery. We also looked at all-cause in-hospital mortality as a secondary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with definitive IE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with patients with definitive infective endocarditis\n\nExclusion Criteria:\n\n* childs'}, 'identificationModule': {'nctId': 'NCT02388893', 'briefTitle': 'Endocarditis Registry of the University Hospital of Cologne (ER-UHC)', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Endocarditis Registry of the University Hospital of Cologne (ER-UHC)', 'orgStudyIdInfo': {'id': '14-221'}, 'secondaryIdInfos': [{'id': '14-221', 'type': 'OTHER', 'domain': 'Ethics committee of the University of Cologne'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Guido Michels, Prof. Dr.', 'role': 'CONTACT', 'email': 'guido.michels@uk-koeln.de', 'phone': '++49-221-478-32401'}], 'facility': 'Heart Center of the University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Guido Michels, Prof. Dr.', 'role': 'CONTACT', 'email': 'guido.michels@uk-koeln.de', 'phone': '++49-221-478-32401'}, {'name': 'Norma Jung, Dr.', 'role': 'CONTACT', 'email': 'norma.jung@uk-koeln.de', 'phone': '++49-221-478-0'}], 'overallOfficials': [{'name': 'Guido Michels, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center, University of Cologne, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Guido Michels', 'investigatorFullName': 'Guido Michels', 'investigatorAffiliation': 'University of Cologne'}}}}