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:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Transthoracic Echocardiography in Assessing Patients With Suspected Endocarditis - Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEASE-Forward
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: