Relevance of Artificial Intelligence-Assisted Echocardiography for Left Ventricular Ejection Fraction Assessment in Geriatric Patients

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorGérond'if

About this trial

Heart failure (HF) is the leading cause of hospitalization among adults aged 80 years and older and represents a major diagnostic challenge in geriatric medicine due to frequently atypical clinical presentations and the presence of multiple comorbidities. Although transthoracic echocardiography (TTE) with measurement of left ventricular ejection fraction (LVEF) remains the gold standard for cardiac functional assessment, access to echocardiography is often limited in geriatric wards.

Recent advances in artificial intelligence (AI) have enabled the development of portable ultrasound devices and automated image analysis software capable of providing reliable and reproducible LVEF measurements. AI-assisted automated LVEF assessment (AutoEF-AI) may therefore represent a valuable alternative to conventional echocardiography for the cardiac evaluation of older patients with heart failure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥75 years.

Hospitalization in a geriatric unit for acute heart failure according to the 2021 ESC diagnostic criteria.

Hemodynamic stability at the time of echocardiographic examination.

Ability to understand study information, provide written informed consent, and willingness to participate.

Disqualifiers

Hemodynamic instability preventing echocardiographic assessment.

Contraindication to transthoracic echocardiography.

Patients under legal protection (guardianship, curatorship, or judicial protection measures) or unable to provide informed consent.

Refusal to participate in the study.

Trial design

Design model

Crossover

Treatments tested in this trial

  • AutoEF-AI Assessment

    Diagnostic test

    Performed by a geriatrician who has completed a one-day practical training session and combines: * A handheld ultrasound device providing real-time image acquisition guidance for obtaining apical views. * Us2.ai software for automated LVEF analysis. The geriatrician is blinded to results of the gold standard echocardiography performed by the cardiologist.

  • Standard Echocardiography (Reference method)

    Diagnostic test

    The standard echocardiography will be performed by an expert cardiologist as part of routine clinical care and will serve as the gold standard

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Standard Echocardiography (Reference method)Other 1 intervention
Group B: AutoEF-AI AssessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography.

Agreement will be assessed using: * Intraclass Correlation Coefficient (ICC) * Spearman correlation coefficient * Bland-Altman analysis * Weighted kappa coefficient for the classification of patients according to LVEF categories (≤40%, 41-49%, and ≥50%)

Time frame
At baseline

Secondary outcomes

1

Diagnostic performance of AutoEF-AI for the detection of LVEF <50%, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.

Calculation of the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy of AutoEF-AI for identifying left ventricular ejection fraction (LVEF) below 50%, compared with the standard reference method.

Time frame
At baseline
2

Analysis of factors associated with agreement between the two methods

Multiple linear regression model will be used to identify clinical and technical variables (age, sex, cardiovascular history, presence of a pacemaker, cardiac arrhythmias, image quality, comorbidities, etc.) associated with a significant discrepancy between LVEF measurements obtained using AutoEF-AI and standard echocardiography.

Time frame
At baseline
3

Feasibility of AutoEF-AI use by a geriatrician after a short training program

* Success rate of valid image acquisition (i.e acquizition of analyzable apical views suitable for automated analysis) * Quality of the acquired images (image quality score and proportion of non-analyzable images) * Difficulties encountered during the use of the AutoEF-AI device

Time frame
At baseline

Other outcomes

Sponsors and contacts

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