Long QT Syndrome, Torsades de Pointe Caused by Drug
Conditions
Brief summary
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
DEVICEBodyGuardian 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot | Through Day 30 | * 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). |
| Frequency of major arrhythmia occurrence | Through Day 30 | * The QT interval will be assessed every 4 hours for the first 5 days and then every 8 hours thereafter |
| Trajectories of QT prolongation | Through day 30 | * 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. |
Countries
United States
Contacts
Primary ContactJoshua D Mitchell, M.D., FACC
Backup ContactKaitlin Moore
Outcome results
None listed