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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
The BodyGuardian Mini Plus attaches to the upper chest of the patient through the use of an adhesive patch. ECG tracings are recorded continuously and sent to the linked smartphone and subsequently to a cloud server.
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGComparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot
* 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).
Time frame: Through Day 30
Frequency of major arrhythmia occurrence
* The QT interval will be assessed every 4 hours for the first 5 days and then every 8 hours thereafter
Time frame: Through Day 30
Trajectories of QT prolongation
* 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.
Time frame: Through day 30
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