Continuous Versus Intermittent cARdiac Electrical moNitorinG

Study Overview
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Brief Summary
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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).

Official Title
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Continuous Versus Intermittent cARdiac Electrical moNitorinG

Conditions
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Torsades de Pointe Caused by Drug, Long QT Syndrome

Intervention / Treatment
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* Device: BodyGuardian Mini Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. Exclusion Criteria: Younger than 18 years of age Allergy to adhesive patches

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous patch monitoring system<br>Participants will receive standard of care treatment with either arsenic trioxide or capecitabine. They will have continuous patch monitor system (BodyGuardian Mini Plus) applied on or prior to the first day of therapy and will receive at least 5 ECGs for comparison during the first 30 days of treatment. Twelve-lead ECGs are routinely performed in patients receiving arsenic trioxide at baseline and twice weekly during the first 4 weeks of therapy. These ECGs (total of up to 9) will be accessed for the purposes of this study. Patients who receive capecitabine do not routinely have ECGs performed after baseline, but for the purposes of this study, two serial ECGs will be conducted on Day 14 and Day 28 of Cycle 1 of treatment (total of 5 including baseline). | Device: BodyGuardian Mini Plus<br>* 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.<br>* Other names: Continuous patch monitoring system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison 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). | 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 | 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. | Through day 30 |