Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 12:45 PM
Study NCT ID:
NCT00524212
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2007-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How to Improve Diagnosis in Infective Endocarditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004697', 'term': 'Endocarditis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D053821', 'term': 'Cardiovascular Infections'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004696', 'term': 'Endocarditis'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'A venous blood sample was obtained from each patients and all samples were centrifuged and immediately frozen.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 761}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-19', 'studyFirstSubmitDate': '2007-08-31', 'studyFirstSubmitQcDate': '2007-08-31', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-03', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endocarditis, Bacterial']}, 'descriptionModule': {'briefSummary': 'The purpose is to exam prospective if simple clinical information in combination with a normal s-procalcitonin are sufficient for exclusion of infective endocarditis (IE).', 'detailedDescription': 'Despite progress in surgical and medical treatment, infective endocarditis is still associated with high morbidity and mortality.\n\nThe variable clinical presentation of IE makes the diagnosis a clinical challenge.\n\nProcalcitonin is a precursor from the hormone calcitonin and also a marker of systemic bacterial infections.\n\nThe purpose of this study is:\n\n* to investigate the diagnostic value of serum procalcitonin (PCT), C-reactive protein (CRP) and sedimentation rate (SR) when IE is suspected.\n* to investigate if a retrospectively generated clinical model suitable for exclusion of IE can be confirmed prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort was selected from all the patients admitted to the tertiary hospital (the initial diagnosis was infective endocarditis)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> or = 18 year with suspected or verified Infective Endocarditis\n* By word of mouth or in writing consent\n\nExclusion Criteria:\n\n* Incapacity'}, 'identificationModule': {'nctId': 'NCT00524212', 'briefTitle': 'How to Improve Diagnosis in Infective Endocarditis', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Ph. D Student, Jane Byriel Knudsen, Aarhus University', 'orgStudyIdInfo': {'id': '06-10-B640-A1205-22345'}, 'secondaryIdInfos': [{'id': '20060181'}, {'id': 'SUN-2007-653'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'IE confirmed IE rejected', 'description': 'Prospective, controlled, blinded study of clinical/TEE criteria of IE compare to clinical/blood test criteria of IE.'}, {'label': 'IE confirmed IE rejected'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Cardiology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Jane B Knudsen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital, Skejby, Department of Cardiology, 8200 Aarhus N, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jane Byriel Knudsen', 'oldOrganization': 'Dept. of Cardiology, Aarhus University Hospital, Skejby - Denmark'}}}}