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Cardiac Monitoring Device
Continuous Cardiac Monitoring for Heart Arrhythmia (CARING Trial)
N/A
Recruiting
Led By Joshua D Mitchell, M.D., FACC
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 30
Awards & highlights
CARING Trial Summary
This trial is testing a new way to monitor heart arrhythmias in people taking medication that could cause heart complications. Results will be compared to the standard ECG test.
Who is the study for?
This trial is for adults over 18 with acute promyelocytic leukemia starting arsenic trioxide treatment, or those with solid tumors beginning capecitabine. Participants must not be allergic to adhesive patches and should be able to understand and sign a consent form.Check my eligibility
What is being tested?
The study is testing the BodyGuardian Mini Plus, a continuous patch monitoring system for cardiac arrhythmias, against standard ECGs in patients taking drugs that may affect the heart.See study design
What are the potential side effects?
Potential side effects are likely related to skin irritation due to the adhesive on the BodyGuardian Mini Plus patch. There might also be discomfort from wearing the device continuously.
CARING Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 30
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot
Frequency of major arrhythmia occurrence
Trajectories of QT prolongation
CARING Trial Design
1Treatment groups
Experimental Treatment
Group I: Continuous patch monitoring systemExperimental Treatment1 Intervention
-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.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,747 Total Patients Enrolled
Joshua D Mitchell, M.D., FACCPrincipal InvestigatorWashington University School of Medicine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have acute promyelocytic leukemia and am starting treatment with arsenic trioxide.I have a solid tumor and am starting treatment with capecitabine.I am starting treatment with ribociclib for my solid tumor.I am 18 years old or older.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous patch monitoring system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being recruited to join this clinical investigation?
"As highlighted on clinicaltrials.gov, this research is not presently welcoming any more participants. It was initially posted on December 31st 2022 and last updated nine months later, in September 3rd 2022. There are 11 other trials that still have open recruitment at the moment however."
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