Continuous Versus Intermittent cARdiac Electrical moNitorinG

NCT ID: NCT04336644

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-21

Study Completion Date

2026-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Torsades de Pointe Caused by Drug Long QT Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

BodyGuardian Mini Plus

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Continuous patch monitoring system

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua D Mitchell, M.D., FACC

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joshua D Mitchell, M.D., FACC

Role: CONTACT

Phone: 314-494-3124

Email: [email protected]

Kaitlin Moore

Role: CONTACT

Phone: 314-273-0830

Email: [email protected]

Facility Contacts

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Joshua D Mitchell, M.D., FACC

Role: primary

Kaitlin Moore

Role: backup

Related Links

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http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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202001147

Identifier Type: -

Identifier Source: org_study_id