VaLidation of the Simple Adaptation of the Kardia 6L ECG Recorder to Obtain Chest leAd equivaLents: a Multi-centre International (LOCAL-ECG) Study; on Behalf of the Africa Heart Rhythm Association Investigators
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of adaptation to handheld 6Lead
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. The aim is to test whether a novel adaptation to a 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 and has implications in the prevention of infection.
The lead author recently published a pilot study showing the clinical utility of this technique and the aim of this study is to validate the method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient who is attending the cardiology clinic or an inpatient on the cardiology ward who consents to taking part
排除标准
- •Patients who are unable or refuse to consent
结局指标
主要结局
Sensitivity and specificity of adaptation to handheld 6Lead
时间窗: 10 Minutes
Sensitivity and specificity of adaptation to handheld 6Lead compared to 12 lead for leads V1 and V6 for the measurement of PR, QRS duration and QT interval
次要结局
- Assessment of other ECG parameters(10 Minutes)