Continuous Versus Intermittent cARdiac Electrical moNitorinG

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Joshua D Mitchell, M.D., FACC
jdmitchell@wustl.edu
314-494-3124
Backup
Kaitlin Moore
kaitlin.m.moore@wustl.edu
314-273-0830
Time Frame
Start Date: 2023-11-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Continuous patch monitoring system
-Participants will receive standard of care treatment with either arsenic trioxide, ribociclib, or capecitabine. They will have continuous patch monitor system (BodyGuardian Mini Plus) applied on or prior to the first day of therapy and will receive at least 5 ECGs for comparison during the first 30 days of treatment.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov