NCT07415369

Transthoracic Echocardiography in Assessing Patients With Suspected Endocarditis

Transthoracic Echocardiography in Assessing Patients With Suspected Endocarditis - Prospective Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Endocarditis Infective

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2026-02-17
• Last updated: 2026-02-17