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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04336644
Other study ID # 202001147
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 21, 2023
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Washington University School of Medicine
Contact Joshua D Mitchell, M.D., FACC
Phone 314-494-3124
Email jdmitchell@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Through Day 30
Primary 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 Through Day 30
Primary 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.
Through day 30
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