Prognostic Role of AI-Echo

NCT07009639 | Recruiting

• 1 other identifier: 58/2025
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Left atrial cardiomyopathy (LACM) is frequently underdiagnosed but plays a key role in increasing the risk of atrial fibrillation (AF) and thromboembolic events. While atrial strain is a validated marker of LACM, its measurement with conventional echocardiography can be time-consuming and less feasible in acute settings. The use of AI-assisted echocardiography (AI-echo) may help streamline image acquisition and analysis, offering faster and potentially more accurate assessment. This study aims to compare the time required for atrial strain analysis using AI-echo versus standard methods. It also explores how changes in strain parameters (LASr, LASct, LAScd) relate to the onset of AF and in-hospital adverse outcomes, adjusting for comorbidities and conventional echo variables. Main endpoints include time reduction with AI-echo and the association between strain changes and AF, complications, or mortality during hospitalization.

Conditions

Atrial Cardiomyopathy

Outcome Measures

Primary Outcomes (5)

• Echocardiographic acquisition times changes

  To compare the duration of echocardiographic image acquisition and atrial strain analysis using an AI-assisted echocardiography software versus the conventional manual method in patients admitted to the Cardiac Intensive Care Unit (CCU). All measurements will be performed using the same ecocardiography machine and by the same operator to ensure consistency. The outcome will be assessed by measuring the time (in minutes) required to complete image acquisition and atrial strain analysis with each method.

  From the start of echocardiographic acquisition to the completion of atrial strain analysis

• Change in left atrial reservoir strain (LASr) between admission and discharge

  To assess the variation in left atrial reservoir strain (LASr), measured by speckle-tracking echocardiography, between hospital admission and discharge in patients admitted to the Cardiac Intensive Care Unit (CCU). Measurements will be performed in each patient at two time points: within 24 hours of admission and within 24 hours prior to discharge.

  At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)

• Change in left atrial conduit strain (LAScd) between admission and discharge

  To assess the variation in left atrial conduit strain (LAScd), measured by speckle-tracking echocardiography, between hospital admission and discharge in patients admitted to the Cardiac Intensive Care Unit (CCU). Measurements will be performed in each patient at two time points: within 24 hours of admission and within 24 hours prior to discharge.

  At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)

• Change in left atrial contractile strain (LASct) between admission and discharge Description

  To assess the variation in left atrial contractile strain (LASct), measured by speckle-tracking echocardiography, between hospital admission and discharge in patients admitted to the Cardiac Intensive Care Unit (CCU). Measurements will be performed in each patient at two time points: within 24 hours of admission and within 24 hours prior to discharge.

  At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)

• Correlation between atrial strain variation (ΔLASr, ΔLASct, ΔLAScd) and in-hospital heart failure worsening

  To evaluate whether changes in atrial strain parameters (ΔLASr, ΔLASct, ΔLAScd), measured via speckle-tracking echocardiography, correlate with the incidence of in-hospital worsening of heart failure (Unit of Measure: % of patients with in-hospital worsening heart failure). Worsening is defined as the need for intensification of diuretic therapy, initiation of inotropes, transfer to higher-level care, or an increase in NT-proBNP levels compared to baseline (measured in pg/mL).

  From admission (within 24 hours of enrollment) to discharge (within 24 hours before discharge)

Secondary Outcomes (3)

• Incidence of in-hospital procedural complications

  Through study completion, an average of 7 days

• Incidence of in-hospital infections

  Through study completion, an average of 7 days

• Incidence of in-hospital thromboembolic events

  Through study completion, an average of 7 days

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-85 years, in sinus rhythm at the time of enrollment, with an indication for echocardiography for acute cardiac pathology.

You may qualify if:

• Age between 18 and 85 years.
• Hospitalization in CCU for acute cardiac pathology (e.g. acute coronary syndrome, acute or exacerbated heart failure, malignant arrhythmias, etc.).
• Ability to provide written informed consent.

You may not qualify if:

• Severe hemodynamic instability, history to contraindicate the execution of the echocardiographic examination.
• Severely inadequate echocardiographic window that precludes atrial or ventricular morpho-functional assessment.
• Inability to continue the study for clinical reasons, logistics or patient refusal.

Sponsors & Collaborators

• University of Calabria: lead

Study Sites (1)

"Annunziata" Hospital

Cosenza, 87100, Italy

RECRUITING

Central Study Contacts

Antonio Curcio, Medicine

CONTACT

+390984681877; antonio.curcio.cardio@unical.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 6, 2025
• Study Start: July 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 30, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)