Relevance of Artificial Intelligence-Assisted Echocardiography for Left Ventricular Ejection Fraction Assessment in Geriatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography.
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard Echocardiography (Reference method)
The standard echocardiography will be performed by a cardiologist as part of routine clinical care.
干预措施: Standard Echocardiography (Reference method) (Diagnostic Test)
AutoEF-AI Assessment
AI-assisted automated LVEF assessment
干预措施: AutoEF-AI Assessment (Diagnostic Test)
结局指标
主要结局
Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography.
时间窗: At baseline
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%)
次要结局
- Diagnostic performance of AutoEF-AI for the detection of LVEF <50%, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.(At baseline)
- Analysis of factors associated with agreement between the two methods(At baseline)
- Feasibility of AutoEF-AI use by a geriatrician after a short training program(At baseline)