Continuous Versus Intermittent cARdiac Electrical moNitorinG
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Younger than 18 years of age
Allergy to adhesive patches
Trial design
Design model
Single group
Treatments tested in this trial
BodyGuardian Mini Plus
DeviceThe 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Continuous patch monitoring systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot
* The Bland Altman plot provides a graphical method to compare the question of interest, namely that the measurements derived from the patch monitor are accurate in relation to the gold standard of the ECG. * Each QT measured from the tracing will be plotted against the difference in QT between the tracing and the 12-lead ECG. The acceptable difference between measurement techniques will be set at 5 ms (primary, strict threshold based on FDA recommendations) with a clinically acceptable difference of 15 ms (based on known variability in 12-lead ECG recordings).
Time frame
Through Day 302
Frequency of major arrhythmia occurrence
* The QT interval will be assessed every 4 hours for the first 5 days and then every 8 hours thereafter
Time frame
Through Day 303
Trajectories of QT prolongation
* Will assess the QT interval every four hours for five days after drug initiation and after five days, the QTc will be assessed every 8 hours * With this data, the investigators will plot the QTc interval (Fridericia correction) over time and determine the time of expected peak effect. Outliers will be reviewed and verified manually.
Time frame
Through day 30Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov