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Continuous Cardiac Monitoring for Drug-Induced Heart Complications

This study is testing a continuous heart monitoring system called BodyGuardian Mini Plus. This device attaches to your chest and continuously records your heart's electrical activity (ECG tracings). The goal is to see how well this system compares to standard ECGs in detecting heart rhythm problems like Torsades de Pointe (a type of irregular heartbeat) and Long QT Syndrome (a heart condition that can cause fast, chaotic heartbeats). You might be able to join if you are at least 18 years old and are starting treatment for acute promyelocytic leukemia with arsenic trioxide, or a solid tumor with capecitabine or ribociclib. The study is looking at how often major arrhythmias happen and changes in QT prolongation over 30 days. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 60 participants. It aims to compare the BodyGuardian Mini Plus device with standard electrocardiograms.
What's involved
You would wear the BodyGuardian Mini Plus device, which records your heart's electrical activity continuously for up to 30 days.
Compensation
Not stated in the trial record.
Follow-up
Your heart activity will be monitored and evaluated for up to 30 days after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04336644

Continuous Versus Intermittent cARdiac Electrical moNitorinG

Recruiting
NAAges 18+InterventionalDiagnostic
Washington University School of Medicine
~60 participants
Updated 2025-12-30 on ClinicalTrials.gov
What's tested:BodyGuardian Mini Plus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot
Measured over Through Day 30
+2 more outcomes measured

Conditions

Torsades de Pointe Caused by Drug
Long QT Syndrome

Explore related trials

Acute Promyelocytic LeukemiaSolid Neoplasm

NCT04336644

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Washington University School of Medicine

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Joshua D Mitchell, M.D., FACC · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Joshua D Mitchell, M.D., FACC
[email protected]
314-494-3124
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

Younger than 18 years of age
Allergy to adhesive patches

What this trial measures

  • Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman PlotThrough 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 occurrenceThrough Day 30

    * The QT interval will be assessed every 4 hours for the first 5 days and then every 8 hours thereafter

  • Trajectories of QT prolongationThrough 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.