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NCT Number: NCT07009639

Prognostic Role of AI-Echo

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

"Annunziata" Hospital

Cosenza, 87100, Italy

Location status: Recruiting

Location contact

Antonio Curcio

CONTACT

[email protected]

+390984681877

Letizia R Romano

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  1. Incidence of in-hospital procedural complications

    Time frame: Through study completion, an average of 7 days

    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.

  2. Incidence of in-hospital infections

    Time frame: Through study completion, an average of 7 days

    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.

  3. Incidence of in-hospital thromboembolic events

    Time frame: Through study completion, an average of 7 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Curcio, Medicine

CONTACT

[email protected]

+390984681877

Sponsors and collaborators

Lead sponsor

University of Calabria

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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