Clinical Validation of an iPhone ECG System, QT Substudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- QT interval measurement (in milliseconds)
研究概览
简要总结
This study will validate the recording accuracy of a specific electrical interval of the heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead electrocardiogram (ECG). These measurements will occur in hospitalized patients that are starting either sotalol or dofetilide, since both of these medications can prolong the QT interval.
详细描述
Patients that were already selected to begin either dofetilide or sotalol in the hospital, will be included in the study. Patients will receive an ECG before and 2 hours after each dose of the medication, which is done to monitor the QT interval. In addition, patients that consent to participate in the study will have an iPhone ECG recording taken in lead positions that correspond to leads I,II, and III.
These recordings will be compared and analyzed to assess the accuracy of the QT interval recordings between the two methods.
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
- 是
入选标准
- •initiation of sotalol or dofetilide
- •inpatient at University hospital
排除标准
- 未提供
研究组 & 干预措施
iPhone ECG QT recording
iPhone ECG
干预措施: iPhone ECG (Device)
结局指标
主要结局
QT interval measurement (in milliseconds)
时间窗: Participants will be followed for duration of hospital stay during which dofetilide or sotalol are being started, an expected average of 3 days
The QT interval (measured from the start of the QRS to the end of the T wave) will be measured on the 12-lead ECG and on the iPhone rhythm strip recording. Both measurements will be recorded in milliseconds and will be statistically analyzed for bias and agreement.
次要结局
未报告次要终点