Continuous Versus Intermittent cARdiac Electrical moNitorinG
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Trajectories of QT prolongation
研究概览
简要总结
The purpose of this study is to validate the continuous patch monitoring system to evaluate cardiac arrhythmias in patients receiving drugs that can cause cardiac complications and compare the continuous patch system with standard electrocardiograms (ECGs).
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
- 否
入选标准
- •Diagnosis of acute promyelocytic leukemia (APL) and being initiated on standard of care arsenic trioxide OR Diagnosis of solid tumor and being initiated on standard of care capecitabine (alone or as part of combination treatment) OR Diagnosis of solid tumor and being initiated on standard of care ribociclib (alone or as part of combination treatment)
- •At least 18 years of age.
- •No allergy to adhesive patches.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Younger than 18 years of age
- •Allergy to adhesive patches
结局指标
主要结局
Trajectories of QT prolongation
时间窗: Through day 30
* Will assess the QT interval every four hours for five days after drug initiation and after five days, the QTc will be assessed every 8 hours * With this data, the investigators will plot the QTc interval (Fridericia correction) over time and determine the time of expected peak effect. Outliers will be reviewed and verified manually.
Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot
时间窗: Through Day 30
* The Bland Altman plot provides a graphical method to compare the question of interest, namely that the measurements derived from the patch monitor are accurate in relation to the gold standard of the ECG. * Each QT measured from the tracing will be plotted against the difference in QT between the tracing and the 12-lead ECG. The acceptable difference between measurement techniques will be set at 5 ms (primary, strict threshold based on FDA recommendations) with a clinically acceptable difference of 15 ms (based on known variability in 12-lead ECG recordings).
Frequency of major arrhythmia occurrence
时间窗: Through Day 30
* The QT interval will be assessed every 4 hours for the first 5 days and then every 8 hours thereafter
次要结局
未报告次要终点