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

Обзор

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.

Подробное описание

Prospective, single-center interventional study comparing two methods of left ventricular ejection fraction measurement in patients aged 75 years and older hospitalized for acute heart failure.Each hemodynamically stable participant will undergo two echocardiographic examinations performed within 24 hours:

* Standard Echocardiography (Reference Method) * AI-assisted automated LVEF assessment (AutoEF-AI)

Вмешательства

• Диагностический тест AutoEF-AI Assessment
  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.
• Диагностический тест Standard Echocardiography (Reference method)
  The standard echocardiography will be performed by an expert cardiologist as part of routine clinical care and will serve as the gold standard

Первичные конечные точки

• Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography. [Срок оценки: At baseline]

Вторичные конечные точки (3)

• Diagnostic performance of AutoEF-AI for the detection of LVEF <50%, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. [Срок оценки: At baseline]
• Analysis of factors associated with agreement between the two methods [Срок оценки: At baseline]
• Feasibility of AutoEF-AI use by a geriatrician after a short training program [Срок оценки: At baseline]

Критерии участия

Критерии включения

• 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.
• Affiliation with, or beneficiary of, a health insurance/social security scheme.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Broca Hospital — Paris

Идентификаторы

NCT: NCT07701369 · 2025-A02039-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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