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Recruiting

NCT Number: NCT04336644

Continuous Versus Intermittent cARdiac Electrical moNitorinG

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Joshua D Mitchell, M.D., FACC

CONTACT

[email protected]

314-494-3124

Joshua D Mitchell, M.D., FACC

PRINCIPAL_INVESTIGATOR

Kaitlin Moore

CONTACT

[email protected]

314-273-0830

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (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 criteria

  • Younger than 18 years of age
  • Allergy to adhesive patches

Treatment and study plan

BodyGuardian Mini Plus

Device

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.

Other names: Continuous patch monitoring system

Primary outcomes

  1. Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot

    Time frame: 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).
  2. Frequency of major arrhythmia occurrence

    Time frame: Through Day 30

    • The QT interval will be assessed every 4 hours for the first 5 days and then every 8 hours thereafter
  3. Trajectories of QT prolongation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua D Mitchell, M.D., FACC

CONTACT

[email protected]

314-494-3124

Kaitlin Moore

CONTACT

[email protected]

314-273-0830

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: CARING

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2020
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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