Back to resultsContinuous Versus Intermittent cARdiac Electrical moNitorinG (CARING)
Primary Purpose
Torsades de Pointe Caused by Drug, Long QT Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BodyGuardian Mini Plus
Sponsored by
About this trial
This is an interventional screening trial for Torsades de Pointe Caused by Drug
Eligibility Criteria
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
- 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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Continuous patch monitoring system
Arm Description
Participants will receive standard of care treatment with either arsenic trioxide 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. Twelve-lead ECGs are routinely performed in patients receiving arsenic trioxide at baseline and twice weekly during the first 4 weeks of therapy. These ECGs (total of up to 9) will be accessed for the purposes of this study. Patients who receive capecitabine do not routinely have ECGs performed after baseline, but for the purposes of this study, two serial ECGs will be conducted on Day 14 and Day 28 of Cycle 1 of treatment (total of 5 including baseline).
Outcomes
Primary Outcome Measures
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).
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04336644
First Posted
April 2, 2020
Last Updated
September 19, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04336644
Brief Title
Continuous Versus Intermittent cARdiac Electrical moNitorinG
Acronym
CARING
Official Title
Continuous Versus Intermittent cARdiac Electrical moNitorinG
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Torsades de Pointe Caused by Drug, Long QT Syndrome
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous patch monitoring system
Arm Type
Experimental
Arm Description
Participants will receive standard of care treatment with either arsenic trioxide 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.
Twelve-lead ECGs are routinely performed in patients receiving arsenic trioxide at baseline and twice weekly during the first 4 weeks of therapy. These ECGs (total of up to 9) will be accessed for the purposes of this study. Patients who receive capecitabine do not routinely have ECGs performed after baseline, but for the purposes of this study, two serial ECGs will be conducted on Day 14 and Day 28 of Cycle 1 of treatment (total of 5 including baseline).
Intervention Type
Device
Intervention Name(s)
BodyGuardian Mini Plus
Other Intervention Name(s)
Continuous patch monitoring system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of blinded, manual measurements of the ECGs to the patch monitor tracings as measured by the Bland-Altman Plot
Description
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).
Time Frame
Through Day 30
Title
Frequency of major arrhythmia occurrence
Description
The QT interval will be assessed every 4 hours for the first 5 days and then every 8 hours thereafter
Time Frame
Through Day 30
Title
Trajectories of QT prolongation
Description
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.
Time Frame
Through day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua D Mitchell, M.D., FACC
Phone
314-273-1698
Email
jdmitchell@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitlin Moore
Phone
314-273-0830
Email
kaitlin.m.moore@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua D Mitchell, M.D., FACC
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua D Mitchell, M.D., FACC
Phone
314-273-1698
Email
jdmitchell@wustl.edu
First Name & Middle Initial & Last Name & Degree
Kaitlin Moore
Phone
314-273-0830
Email
kaitlin.m.moore@wustl.edu
First Name & Middle Initial & Last Name & Degree
Joshua D Mitchell, M.D., FACC
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. We may also share your research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If your individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at your information.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Please email any proposals to jdmitchell@wustl.edu.
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Continuous Versus Intermittent cARdiac Electrical moNitorinG
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