Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04977518
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2021-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristics of Infective Endocarditis in East China
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications (neurological events, systemic embolism, and congestive heart failure) of infective endocarditis', 'timeFrame': 'During the hospitalization, average of 1 months', 'description': '1. A neurological event was defined as symptomatic or asymptomatic stroke, hemorrhage, or encephalopathy.\n2. Systemic embolization was defined as an embolic event outside of the central nervous system.\n3. Congestive heart failure was defined as with class III, or IV heart failure and an ejection fraction of 40% or less.'}, {'measure': 'Mortality', 'timeFrame': 'During the hospitalization, average of 1 months', 'description': 'Patients dead or moribund before discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infective Endocarditis']}, 'descriptionModule': {'briefSummary': 'This was a retrospective observational study of consecutive cases of definite or possible infective endocarditis (IE) as per the modified Duke criteria between January 2008 and December 2015, which was performed at the Second Affiliated Hospital of Zhejiang University, School of medicine (SAHZU), a tertiary care referral hospital located in East China.', 'detailedDescription': 'Infective endocarditis (IE) is a rare but life-threatening serious disease that still has a high mortality, even in developed countries. The objective of this study was to evaluate the clinical presentations, treatment and outcomes of IE patients in a tertiary hospital in East China over an 8-year period. This was a retrospective observational study of consecutive cases of definite or possible IE as per the modified Duke criteria between January 2008 and December 2015.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a clinical diagnosis of infective endocarditis between January 2008 and December 2015 in a tertiary hospital located in the East China', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a clinical diagnosis of infective endocarditis.\n\nExclusion Criteria:\n\n* Patients did not meet the modified Duke criteria.'}, 'identificationModule': {'nctId': 'NCT04977518', 'briefTitle': 'Characteristics of Infective Endocarditis in East China', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Study of the Clinical Presentations, Treatment and Outcomes of Infective Endocarditis Patients in a Tertiary Hospital in East China', 'orgStudyIdInfo': {'id': '2015-046'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients diagnosed during 2008-2011', 'description': 'Patients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2008-2011', 'interventionNames': ['Other: no intervention']}, {'label': 'Patients diagnosed during 2012-2015', 'description': 'Patients diagnosed with definite and probable infective endocarditis defined according to the modified Duke clinical criteria during 2012-2015', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Patients diagnosed during 2008-2011', 'Patients diagnosed during 2012-2015']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Huimin Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data shared by published papers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}