Transthoracic Echocardiography in Assessing Patients With Suspected Endocarditis (TEASE-Forward)

February 12, 2026 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Transthoracic Echocardiography in Assessing Patients With Suspected Endocarditis - Prospective Study

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

350

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

  • age over 18 years;
  • patients who underwent transoesophageal echocardiography (TOE) for suspected infective endocarditis within 15 days of a transthoracic exam (TTE).

Exclusion Criteria:

- diagnosis of endocarditis was made in another center.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint of the study is the diagnosis of infective endocarditis during hospitalization.
Time Frame: Periprocedural
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.
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7899

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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