The Clinical Utility of Artificial Intelligence-enabled Electrocardiograms in the Outpatient Practice - Diagnosing Aortic Stenosis and Diastolic Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Number of patients with positive AI-ECG
研究概览
简要总结
Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 60 years of age must have a clinical scheduled ECG performed.
排除标准
- •< 59 years of age
- •Is not scheduled for a clinical ECG
- •Unable to provide consent.
研究组 & 干预措施
Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic.
干预措施: AI-ECG Dashboard (Device)
Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic.
干预措施: Point of care ultrasound (POCUS) (Diagnostic Test)
结局指标
主要结局
Number of patients with positive AI-ECG
时间窗: Baseline
Positive AI-ECG will be determined by the sensitivity, specificity, positive predictive value, and negative predictive value.
Number of studies with reasonable image quality in patients with positive AI-ECG
时间窗: Baseline
Image quality will be determined by sonographers at the time of imaging and will be scored on a scale from 1-4: 1. Excellent , sufficient for publication 2. Good, sufficient for data analysis 3. Fair, just enough for data analysis without complete views 4. Poor, not usable for data analysis
次要结局
- Number of times the AI ECG and TTE (transthoracic echocardiogram) are statistically comparative(Baseline)
研究者
Jae K. Oh, M.D.
Principal Investigator
Mayo Clinic