An observational study in Endocarditis Infective, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
Eligible 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.
Clinical, laboratory, and echocardiographic variables will be collected to characterize the study population and support analyses of diagnostic performance and in-hospital outcomes.
Consecutive patients who undergo TOE for suspected infective endocarditis within 15 days after a TTE will be included.
Patients whose diagnosis of endocarditis was established at another center will be excluded.
For 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).
These data will be used to describe the cohort and to explore how clinical context influences the ability of TTE to rule out IE.
As a secondary endpoint, we will evaluate also the in-hospital outcomes of these patients.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 350 is above the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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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).
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Exclusion Criteria:
- diagnosis of endocarditis was made in another center.
The primary endpoint of the study is the diagnosis of infective endocarditis during hospitalization.
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.
Time frame: Periprocedural
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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