Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Number of First-Degree Relatives to complete the AI-ECG
研究概览
简要总结
The purpose of this study is to assess the feasibility and impact of screening FDR of DCM probands using a mobile ECG with the ability to transmit the ECG for cloud-based AI analysis to detect reduced left ventricular ejection fraction (LVEF). This protocol will examine the impact of incorporating the screening AI enhanced ECG into standard of care recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of First-Degree Relatives to complete the AI-ECG
时间窗: Baseline
Measured by the number of complete transmissions from the Kardia 6-lead device to the AI-ECG algorithm.
Number of First-Degree relatives to complete cardiac screening
时间窗: Baseline
The following screening procedures will be considered a valid cardiac screening attempt: * Scheduled or Completed TTE * Scheduled or completed clinician visit for the purposes of generating a cardiac evaluation
次要结局
- Number of subjects with an Left Ventricular Ejection Fraction ≤ 45%(Baseline)
研究者
Naveen L. Pereira
Principal Investigator
Mayo Clinic