Clinical trial NCT07009639: Prognostic Role of AI-Echo
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Cardiomyopathy
Lead sponsor: University of Calabria
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Echocardiographic acquisition times changes
timeFrame: From the start of echocardiographic acquisition to the completion of atrial strain analysis
measure: Change in left atrial reservoir strain (LASr) between admission and discharge
timeFrame: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
measure: Change in left atrial conduit strain (LAScd) between admission and discharge
timeFrame: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
measure: Change in left atrial contractile strain (LASct) between admission and discharge Description
timeFrame: At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)
measure: Correlation between atrial strain variation (ΔLASr, ΔLASct, ΔLAScd) and in-hospital heart failure worsening
timeFrame: From admission (within 24 hours of enrollment) to discharge (within 24 hours before discharge)
Secondary outcomes:
measure: Incidence of in-hospital procedural complications
timeFrame: Through study completion, an average of 7 days
measure: Incidence of in-hospital infections
timeFrame: Through study completion, an average of 7 days
measure: Incidence of in-hospital thromboembolic events
timeFrame: Through study completion, an average of 7 days
Other outcomes:
Locations:
city: Cosenza
country: Italy
facility: "Annunziata" Hospital
Study officials:
References: