Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-01 @ 8:14 AM
Study NCT ID:
NCT07108803
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-07
First Post:
2025-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004696', 'term': 'Endocarditis'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early post-operative mortality', 'timeFrame': 'Mortality at 1 year after surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infective endocarditis', 'Cardiac surgery', 'Outcomes', 'Risk score', 'Prediction', 'In-hospital mortality', 'Pathogen agents', 'Statistics', 'Sepsis', 'Surgical techniques', 'Epidemiology'], 'conditions': ['Infective Endocarditis (IE)']}, 'descriptionModule': {'briefSummary': 'The European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE) is a nascent large surgical registry that would encompass most relevant aspects of IE in Europe in the contemporary era.', 'detailedDescription': 'ERGOSTE, Purposes:\n\n* To create a European multicenter retrospective database including a large number of patients undergoing surgical treatment for infective endocarditis (IE).\n* To perform epidemiologic analyses of IE-patients and involved pathogens.\n* To find independent predictors of early post-operative death.\n* To test ALL the scoring systems specifically developed to predict early death after surgery for infective endocarditis.\n* To devise a specific risk score for early postoperative death.\n* To explore early and late outcomes of these very difficult patients in order to establish optimal indications, techniques and timing of surgery.\n* To carry out a number of sub-analyses concerning the demographic parameters and variable clinical presentation of patients, type and severity of cardiac structural involvement, adopted valve prostheses and surgical techniques, and different involved microbiologic agents.\n* To lay experiential foundations of a prospective database on the topic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardiac surgery due to infective endocarditis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cardiac surgery due to infective endocarditis\n\nExclusion Criteria:\n\n* Patients under 18 years'}, 'identificationModule': {'nctId': 'NCT07108803', 'acronym': 'ERGOSTE', 'briefTitle': 'European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis', 'organization': {'class': 'UNKNOWN', 'fullName': 'Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)'}, 'officialTitle': 'European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE)', 'orgStudyIdInfo': {'id': '386_2024'}}, 'contactsLocationsModule': {'locations': [{'zip': '34151', 'city': 'Trieste', 'state': 'TRIESTE', 'country': 'Italy', 'facility': 'Cardiac Surgery Unit - ASUGI', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)', 'class': 'UNKNOWN'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giuseppe Gatti', 'investigatorAffiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)'}}}}