Recruiting NCT04336644
Continuous Versus Intermittent cARdiac Electrical moNitorinG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BodyGuardian Mini Plus.
- Who it may be relevant to
- Registry conditions: Torsades de Pointe Caused by Drug, Long QT Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- Device 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 measures
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT04336644 · 202001147