EKO SENSORA: Detecting Clinically Significant Murmurs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Number of new clinically significant heart murmurs detected
研究概览
简要总结
The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023).
The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction.
The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope.
- •Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/Transient ischemic attack, prior cardiac surgery or angiography
排除标准
- •Contact isolation patients
- •Pediatric patients under the age of 18
研究组 & 干预措施
Eko Device
Patients with cardiac risk factors
干预措施: Eko Sensora (Device)
结局指标
主要结局
Number of new clinically significant heart murmurs detected
时间窗: through study completion, an average of 90 days
次要结局
- Number of echocardiograms ordered(through study completion, an average of 90 days)