Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 1:55 AM
Study NCT ID:
NCT07415369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transthoracic Echocardiography in Assessing Patients With Suspected Endocarditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of the study is the diagnosis of infective endocarditis during hospitalization.', 'timeFrame': 'Periprocedural', 'description': 'The purpose of our study was to evaluate the accuracy of TTE in ruling out IE in order to avoid unnecessary TOE, a more invasive and expensive diagnostic exam.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endocarditis Infective']}, 'descriptionModule': {'briefSummary': 'This single-center, prospective observational study evaluates the accuracy of transthoracic echocardiography (TTE) to rule out infective endocarditis (IE) in patients with suspected IE, with the goal of reducing unnecessary transesophageal echocardiography (TOE), a more invasive diagnostic test.\n\nEligible patients are those admitted to the Department of Cardiovascular Sciences at Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome, Italy) who undergo TOE for suspected IE within 15 days of a TTE.\n\nClinical, laboratory, and echocardiographic variables will be collected to characterize the study population and support analyses of diagnostic performance and in-hospital outcomes.', 'detailedDescription': 'Consecutive patients who undergo TOE for suspected infective endocarditis within 15 days after a TTE will be included.\n\nPatients whose diagnosis of endocarditis was established at another center will be excluded.\n\nFor each participant, the study will collect demographics (age, sex, BMI), predisposing conditions (e.g., valvular prosthesis or intracardiac device, immunodeficiency, valvular heart disease), potentially modifiable risk factors (e.g., recent dental procedure or surgery, intravenous drug use), blood culture results, infections diagnosed at the time of TOE, clinical evidence of pulmonary and/or systemic embolization, blood tests, in-hospital mortality, and relevant comorbidities (e.g., chronic kidney failure, respiratory insufficiency, prior acute coronary syndrome or stroke, critical limb ischemia).\n\nThese data will be used to describe the cohort and to explore how clinical context influences the ability of TTE to rule out IE.\n\nAs a secondary endpoint, we will evaluate also the in-hospital outcomes of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to our Department of Cardiovascular Sciences of the University Hospital Agostino Gemelli IRCCS, Rome, Italy, who underwent transoesophageal echocardiography (TOE) for suspected infective endocarditis within 15 days of a transthoracic exam (TTE).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 years;\n* patients who underwent transoesophageal echocardiography (TOE) for suspected infective endocarditis within 15 days of a transthoracic exam (TTE).\n\nExclusion Criteria:\n\n\\- diagnosis of endocarditis was made in another center.'}, 'identificationModule': {'nctId': 'NCT07415369', 'acronym': 'TEASE-Forward', 'briefTitle': 'Transthoracic Echocardiography in Assessing Patients With Suspected Endocarditis', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Transthoracic Echocardiography in Assessing Patients With Suspected Endocarditis - Prospective Study', 'orgStudyIdInfo': {'id': '7899'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}