Evaluation of Artificial Intelligence-Assisted Echocardiography (AI-echo) in the Early Diagnosis and Prognostic Stratification of Left Atrial Cardiomyopathy (LACM) in Patients With Acute Cardiac Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Echocardiographic acquisition times changes
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Echocardiographic acquisition times changes
Time Frame: From the start of echocardiographic acquisition to the completion of atrial strain analysis
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.
Change in left atrial reservoir strain (LASr) between admission and discharge
Time Frame: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before 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.
Change in left atrial conduit strain (LAScd) between admission and discharge
Time Frame: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before 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.
Change in left atrial contractile strain (LASct) between admission and discharge Description
Time Frame: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
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.
Correlation between atrial strain variation (ΔLASr, ΔLASct, ΔLAScd) and in-hospital heart failure worsening
Time Frame: From admission (within 24 hours of enrollment) to discharge (within 24 hours before discharge)
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).
Secondary Outcomes
- 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)
Investigators
Antonio Curcio
Professor
University of Calabria