Comparing continuous and intermittent heart monitoring methods
Continuous Versus Intermittent cARdiac Electrical moNitorinG
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT04336644 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with acute promyelocytic leukemia or solid tumors who are starting treatment with arsenic trioxide, capecitabine, or ribociclib.
Not a fit: Patients under 18 years of age or those with allergies to adhesive patches may not benefit from this study.
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 performed: Other studies have shown promise in using continuous monitoring systems for cardiac arrhythmias, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.