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Recruiting NCT07009639

Prognostic Role of AI-Echo

Observational Atrial Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atrial Cardiomyopathy. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • Echocardiographic acquisition times changes [Time frame: From the start of echocardiographic acquisition to the completion of atrial strain analysis]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
Secondary outcome measures (3)
  • Incidence of in-hospital procedural complications [Time frame: Through study completion, an average of 7 days]
  • Incidence of in-hospital infections [Time frame: Through study completion, an average of 7 days]
  • Incidence of in-hospital thromboembolic events [Time frame: Through study completion, an average of 7 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • "Annunziata" Hospital — Cosenza

Identifiers

NCT: NCT07009639 · 58/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗