Prognostic Role of AI-Echo
ConditionAtrial Cardiomyopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity of Calabria
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients aged 18-85 years, in sinus rhythm at the time of enrollment, with an indication for echocardiography for acute cardiac pathology.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From the start of echocardiographic acquisition to the completion of atrial strain analysis2
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.
Time frame
At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)3
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.
Time frame
At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)4
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.
Time frame
At admission (within 24 hours of enrollment) and at discharge (within 24 hours before discharge)Secondary outcomes
1
Incidence of in-hospital procedural complications
To assess the incidence of complications (% of patients with at least one procedural complication) related to diagnostic or interventional procedures during hospitalization, including but not limited to pericardial effusion, vascular access complications, and device-related issues. Events will be recorded based on clinical documentation and adjudicated by the clinical team.
Time frame
Through study completion, an average of 7 days2
Incidence of in-hospital infections
To assess the incidence of infections acquired during hospitalization (% of patients with at least one in-hospital infection), defined by clinical diagnosis supported by laboratory/microbiological findings and initiation of antimicrobial therapy.
Time frame
Through study completion, an average of 7 days3
Incidence of in-hospital thromboembolic events
To assess the incidence of thromboembolic events (% of patients with at least one thromboembolic event) during hospitalization, including ischemic stroke, systemic embolism, deep vein thrombosis, or pulmonary embolism, confirmed by imaging and/or laboratory criteria.
Time frame
Through study completion, an average of 7 daysSponsors and contacts
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Source ClinicalTrials.gov