Recruiting

cARdiac Electrical moNitorinG

Sponsor:

Washington University School of Medicine

Code:

NCT04336644

Conditions

Torsades de Pointe Caused by Drug

Long QT Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BodyGuardian Mini Plus

Study Details

Brief summary:

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).

Conditions

Torsades de Pointe Caused by Drug

Long QT Syndrome

Study ID

NCT04336644

Start date

Nov 21, 2023

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Continuous patch monitoring system

-Participants will receive standard of care treatment with either arsenic trioxide, ribociclib, 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.

Interventions

BodyGuardian Mini Plus

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.

Primary outcome measure

  • 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 ]
  • Frequency of major arrhythmia occurrence [ Time Frame: Through Day 30 ]
  • Trajectories of QT prolongation [ Time Frame: Through day 30 ]

Central Contacts and Locations

Central contacts

Joshua D Mitchell, M.D., FACC

314-494-3124jdmitchell@wustl.edu

Kaitlin Moore

314-273-0830kaitlin.m.moore@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Joshua D Mitchell, M.D., FACC

314-494-3124jdmitchell@wustl.edu

Kaitlin Moore

314-273-0830kaitlin.m.moore@wustl.edu

Principal Investigator:

Joshua D Mitchell, M.D., FACC

More Information

Sponsor

Washington University School of Medicine

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-12-30.