An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Cardiology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Difference between the 6 lead and the 12 lead Electrocardiogram
研究概览
简要总结
ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. We wanted to test whether a novel handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment.
详细描述
The aim of analysis is to determine if the handheld 6 lead ECG can be used as a simple screener to identify patients who do not need a 12 lead ECG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours)
排除标准
- •Patients who do not consent to the study
结局指标
主要结局
Difference between the 6 lead and the 12 lead Electrocardiogram
时间窗: 2 minutes
Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.
次要结局
未报告次要终点