Actively Recruiting
Continuous Versus Intermittent Cardiac Electrical Monitoring to Evaluate Arrhythmias in Patients Receiving Arsenic Trioxide, Ribociclib, or Capecitabine
Led by Washington University School of Medicine · Updated on 2025-12-30
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a continuous patch monitoring system called BodyGuardian Mini Plus to detect cardiac arrhythmias in patients treated with drugs that may cause heart complications, such as arsenic trioxide, ribociclib, or capecitabine. The study aims to compare this continuous patch system with standard electrocardiograms (ECGs) to see how well the patch monitors heart activity. Participants receive their usual cancer treatment and will have the BodyGuardian Mini Plus device attached to their upper chest as an adhesive patch. ECG tracings are recorded continuously by the patch and sent to a smartphone and cloud server. During the first 30 days of treatment, participants will have at least five standard ECGs performed to compare with the patch data. Throughout the study, researchers will track and compare measurements from ECGs and the patch monitor, focusing on major arrhythmia events and changes in QT interval over 30 days. Participants will be monitored closely with these devices during this period to assess heart rhythm, with data collected remotely via the patch system. The total participation involves monitoring during the first month of treatment.
CONDITIONS
Brief Title
Continuous Versus Intermittent cARdiac Electrical moNitorinG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute promyelocytic leukemia and starting arsenic trioxide treatment OR diagnosis of solid tumor and starting capecitabine or ribociclib treatment (alone or in combination)
- At least 18 years of age
- No allergy to adhesive patches
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Younger than 18 years of age
- Allergy to adhesive patches
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants receive a continuous patch monitor system (BodyGuardian Mini Plus) applied on or prior to the first day of therapy to continuously record ECG tracings while receiving standard of care treatment.
At least 5 ECG assessments during the 30 days
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
J
Joshua D Mitchell, M.D., FACC
K
Kaitlin Moore
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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