Comparing continuous and intermittent heart monitoring methods
Official title: Continuous Versus Intermittent cARdiac Electrical moNitorinG
Run by Washington University School of Medicine · NCT04336644 · Data updated 2026-11-12
This study is testing a new continuous heart monitoring patch to see if it works better than regular heart tests for patients with certain heart conditions who are taking medications that might cause problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | November 21, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 30, 2025 |
| Trial ID | NCT04336644 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with acute promyelocytic leukemia or solid tumors who are starting treatment with arsenic trioxide, capecitabine, or ribociclib.
✕Probably not a fit
Patients under 18 years of age or those with allergies to adhesive patches may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to validate a continuous patch monitoring system for evaluating cardiac arrhythmias in patients receiving drugs that may cause cardiac complications. It compares the effectiveness of this continuous monitoring system with standard electrocardiograms (ECGs). The focus is on patients diagnosed with conditions such as Torsades de Pointe and Long QT Syndrome, who are undergoing treatment with specific medications. The intervention involves the use of the BodyGuardian Mini Plus device to monitor heart activity continuously.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring of cardiac arrhythmias, enhancing patient safety during treatment with potentially harmful medications.
How similar studies have gone: Other studies have shown promise in using continuous monitoring systems for cardiac arrhythmias, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Washington University School of Medicine
St Louis, Missouri, United States Recruiting
Study contacts
- Principal investigator: Joshua D Mitchell, M.D., FACC — Washington University School of Medicine
- Study coordinator: Joshua D Mitchell, M.D., FACC
- Email: jdmitchell@wustl.edu
- Phone: 314-494-3124
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.