Continuous Versus Intermittent cARdiac Electrical moNitorinG (CARING)

The Washington University

Status: Enrolling

Conditions: Torsades de Pointe Caused by Drug; Long QT Syndrome

Treatments: Device: BodyGuardian Mini Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT04336644

202001147

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Continuous patch monitoring system

Experimental group

Description:

-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.

Treatment:

Device: BodyGuardian Mini Plus