NCT07415369

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

January 21, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 21, 2026

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Periprocedural

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • \- diagnosis of endocarditis was made in another center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 17, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-01