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Beat to Beat A Study in Paediatric, Adolescent and Young Adult Patients Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG

Primary Purpose

Neoplasms, Cardiac Arrhythmia

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
ECG application
12 lead ECG
Sponsored by
Murdoch Childrens Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neoplasms focused on measuring QT prolongation, cancer, paediatric, ECG application, 12 lead ECG

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Paediatric or adolescent diagnosis of cancer AND an inpatient of The Royal Children's Hospital, Melbourne for at least 5 days at the time of consent. Patient age ≥ 7 years at time of eligibility screening If age < 18 years, parent or guardian able to provide consent Parental or participant ( if > 18 years of age) possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check: iPhone (6s or later) with iOS version 15.0 or later defined as iPhone model/iOS version used to complete screening eligibility. Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone. Valid phone number associated with iPhone, ascertained from self-report. Valid email address, ascertained from self-report. Participants or parents need to be able to press down on the wearable device crown for 30 seconds Exclusion Criteria: Unable to wear the wearable device. < 18 years of age without guardian or parent to provide consent. Interpreter required for consent purposes.

Sites / Locations

  • The Royal Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ECG App arm

Arm Description

Participants will be provided with a wearable device on Day 1 and Day 4 whilst admitted in hospital.

Outcomes

Primary Outcome Measures

Recording of a 12 lead ECG and wearable device ECG
12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.
Recording of a 12 lead ECG and wearable device ECG
12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.
Calculation of QT interval by two blinded health professionals
The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).
Calculation of QT interval by two blinded health professionals
The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).

Secondary Outcome Measures

Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
From the analysis of QT measurements from Outcome 2, prolonged or abnormal QTc measurement will be noted. An abnormal QTc is greater than 0.48mm. This data will be collected separately for each patient.
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
From the analysis of QT measurements from Outcome 2, prolonged or abnormal QTc measurement will be noted. An abnormal QTc is greater than 0.48mm. This data will be collected separately for each patient.
Sensitivity calculations of wearable device vs 12 Lead ECG
Sensitivity is calculated only in the participants who are declared to have QTc prolongation (abnormal QTc) and is calculated as the proportion patients with QTc prolongation on the wearable device among those with QTc prolongation on the 12-lead ECG.
Sensitivity calculations of wearable device vs 12 Lead ECG
Sensitivity is calculated only in the participants who are declared to have QTc prolongation (abnormal QTc) and is calculated as the proportion patients with QTc prolongation on the wearable device among those with QTc prolongation on the 12-lead ECG.
Specificity calculations of wearable device vs 12 Lead ECG
Specificity is calculated only in participants who do not have QTc prolongation and is calculated as the proportion patients who do not have QTc prolongation on the wearable device among those who do not have QTc prolongation on the 12-lead ECG.
Specificity calculations of wearable device vs 12 Lead ECG
Specificity is calculated only in participants who do not have QTc prolongation and is calculated as the proportion patients who do not have QTc prolongation on the wearable device among those who do not have QTc prolongation on the 12-lead ECG.
To calculate the interobserver variability between the two health care professional readings of QTc.
The corrected QT interval will be calculated on both the wearable device ECG and the 12 lead ECG for each patient and measured by a health professional. QT interval will be calculated by the health professional by using the QT and RR interval from the ECGs using Frederichia's interval (QTcF = QT divided by cube root of RR). This data will be collected separately for each patient. The standard deviation of the difference in QTc interval between the two observers will be reported.
To calculate the interobserver variability between the two health care professional readings of QTc.
The corrected QT interval will be calculated on both the wearable device ECG and the 12 lead ECG for each patient and measured by a health professional. QT interval will be calculated by the health professional by using the QT and RR interval from the ECGs using Frederichia's interval (QTcF = QT divided by cube root of RR). This data will be collected separately for each patient for each patient The standard deviation of the difference in QTc interval between the two observers will be reported.

Full Information

First Posted
November 7, 2022
Last Updated
August 14, 2023
Sponsor
Murdoch Childrens Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05615376
Brief Title
Beat to Beat A Study in Paediatric, Adolescent and Young Adult Patients Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG
Official Title
Beat to Beat A Prospective Study in Paediatric, Adolescent and Young Adult Patients Aged 7 to 18 Years of Age Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Murdoch Childrens Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective study in paediatric, adolescent and young adult patients aged 7 to 18 years to evaluate the agreement between QTc measured using 12 lead electrocardiogram (ECG) and the wearable device ECG.
Detailed Description
Rationale: Leveraging existing wearable technology has the ability to scale routine screening strategies across large populations and can facilitate ambulatory care. In recent years, wearable technology has rapidly diffused into consumer markets and provides unique opportunities to engage individuals on health issues of personal interest, and to collect personal health data. One example of such technology is the ability to perform electrocardiogram (ECG) type traces on wearable devices. However, utilization of this data source to improve patient outcomes has not been fully realized in the health care field. An app-based heart ECG algorithm that can be remotely analysed for QTc prolongation with potential to then notify the user of such potential irregularities could lead to widespread screening, detection and initiation of treatment solutions (i.e. correction of electrolytes, alteration of exacerbating medications, cardiac monitoring etc). Trial Design: This will be a prospective, single arm, experimental, non-significant risk study conducted with the assistance of eligible participants. Parents or mature minors will download the Beat to Beat app, once consented. Once consented the wearable device will be paired to the parent/guardians phone following the steps provided by the wearable device app. Once the device is paired and the study coordinator has assisted with the download of 'Beat to Beat' app, the patients will then be able to commence the ECG readings. A 12 lead ECG will be performed by the study team and immediately following this, an ECG will be recorded on the wearable device. The wearable device will be placed on the left wrist for a Lead I reading, on the left lower abdomen for a Lead II reading and in the fourth intercostal space left parasternal for a chest V2 Lead reading. Recording of the 12 lead ECG and wearable device ECG will be repeated again 4 days later. Once both timepoints (and two device recordings for each time period) have been completed the ECGs will be retrieved from the Beat to Beat app. Both the 12 lead and wearable device ECG will be de-identified and given a patient identifier before being uploaded into the REDCap database.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Cardiac Arrhythmia
Keywords
QT prolongation, cancer, paediatric, ECG application, 12 lead ECG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ECG App arm
Arm Type
Experimental
Arm Description
Participants will be provided with a wearable device on Day 1 and Day 4 whilst admitted in hospital.
Intervention Type
Device
Intervention Name(s)
ECG application
Intervention Description
The app together with the wearable device will record a V1 (Left wrist) or V2 (left ankle) ECG reading. These measurements will be conducted on Day 1 and Day 4.
Intervention Type
Device
Intervention Name(s)
12 lead ECG
Intervention Description
The 12 lead ECG will measure corrected QT interval by recording RR and QT intervals on Day 1 and Day 4. This will be performed within the same episode of care as the wearable device ECG recording. There is no need to perform both at exactly the same time point, but within a 15 minute window.
Primary Outcome Measure Information:
Title
Recording of a 12 lead ECG and wearable device ECG
Description
12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.
Time Frame
Day 1 of inpatient stay
Title
Recording of a 12 lead ECG and wearable device ECG
Description
12 lead ECG and wearable device ECG recordings will be taken at the time point of care. The wearable device ECG will be placed on the left wrist to record a V1 (lead I) ECG and on the left ankle to record a V2 (lead II) ECG reading from which the QT interval can be calculated.
Time Frame
Day 4 of inpatient stay
Title
Calculation of QT interval by two blinded health professionals
Description
The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).
Time Frame
Day 1 of inpatient stay
Title
Calculation of QT interval by two blinded health professionals
Description
The wearable device ECG and 12 lead ECG will be de-identified and given appropriate study numbers. This data will be listed separately for each patient. The QT interval for each recording will be calculated. This is the time corresponding to beginning of depolarization to repolarization of the ventricles. It is calculated using a standardised approach (Fridericia's formula:QTcF = QT divided by cube root of RR).
Time Frame
Day 4 of inpatient stay
Secondary Outcome Measure Information:
Title
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
Description
From the analysis of QT measurements from Outcome 2, prolonged or abnormal QTc measurement will be noted. An abnormal QTc is greater than 0.48mm. This data will be collected separately for each patient.
Time Frame
Day 1 inpatient stay
Title
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
Description
From the analysis of QT measurements from Outcome 2, prolonged or abnormal QTc measurement will be noted. An abnormal QTc is greater than 0.48mm. This data will be collected separately for each patient.
Time Frame
Day 4 inpatient stay
Title
Sensitivity calculations of wearable device vs 12 Lead ECG
Description
Sensitivity is calculated only in the participants who are declared to have QTc prolongation (abnormal QTc) and is calculated as the proportion patients with QTc prolongation on the wearable device among those with QTc prolongation on the 12-lead ECG.
Time Frame
Day 1 inpatient stay
Title
Sensitivity calculations of wearable device vs 12 Lead ECG
Description
Sensitivity is calculated only in the participants who are declared to have QTc prolongation (abnormal QTc) and is calculated as the proportion patients with QTc prolongation on the wearable device among those with QTc prolongation on the 12-lead ECG.
Time Frame
Day 4 inpatient stay
Title
Specificity calculations of wearable device vs 12 Lead ECG
Description
Specificity is calculated only in participants who do not have QTc prolongation and is calculated as the proportion patients who do not have QTc prolongation on the wearable device among those who do not have QTc prolongation on the 12-lead ECG.
Time Frame
Day 1 inpatient stay
Title
Specificity calculations of wearable device vs 12 Lead ECG
Description
Specificity is calculated only in participants who do not have QTc prolongation and is calculated as the proportion patients who do not have QTc prolongation on the wearable device among those who do not have QTc prolongation on the 12-lead ECG.
Time Frame
Day 4 inpatient stay
Title
To calculate the interobserver variability between the two health care professional readings of QTc.
Description
The corrected QT interval will be calculated on both the wearable device ECG and the 12 lead ECG for each patient and measured by a health professional. QT interval will be calculated by the health professional by using the QT and RR interval from the ECGs using Frederichia's interval (QTcF = QT divided by cube root of RR). This data will be collected separately for each patient. The standard deviation of the difference in QTc interval between the two observers will be reported.
Time Frame
Day 1 inpatient stay
Title
To calculate the interobserver variability between the two health care professional readings of QTc.
Description
The corrected QT interval will be calculated on both the wearable device ECG and the 12 lead ECG for each patient and measured by a health professional. QT interval will be calculated by the health professional by using the QT and RR interval from the ECGs using Frederichia's interval (QTcF = QT divided by cube root of RR). This data will be collected separately for each patient for each patient The standard deviation of the difference in QTc interval between the two observers will be reported.
Time Frame
Day 4 inpatient stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Paediatric or adolescent diagnosis of cancer AND an inpatient of The Royal Children's Hospital, Melbourne for at least 5 days at the time of consent. Patient age ≥ 7 years at time of eligibility screening If age < 18 years, parent or guardian able to provide consent Parental or participant ( if > 18 years of age) possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check: iPhone (6s or later) with iOS version 15.0 or later defined as iPhone model/iOS version used to complete screening eligibility. Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone. Valid phone number associated with iPhone, ascertained from self-report. Valid email address, ascertained from self-report. Participants or parents need to be able to press down on the wearable device crown for 30 seconds Exclusion Criteria: Unable to wear the wearable device. < 18 years of age without guardian or parent to provide consent. Interpreter required for consent purposes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lane Collier
Phone
03 9936 6324
Email
acor@mcri.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
A/Prof Rachel Conyers
Phone
03 9345 5522 pager 5601
Email
rachel.conyers@rch.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A/Prof Rachel Conyers
Organizational Affiliation
The Royal Children's Hospital/Murdoch Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lane Collier
Phone
03 9936 6324
Email
acor@mcri.edu.au
First Name & Middle Initial & Last Name & Degree
Dr Claudia Toro
First Name & Middle Initial & Last Name & Degree
Lane Collier

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified data set collected for this analysis of the Beat to Beat trial will be available 12 months after publication of the primary outcome. The study protocol, analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au.
IPD Sharing Time Frame
The de-identified data set collected for the analysis of the trial will be available for six months after publication of the primary outcome. The study protocol can be obtained from Murdoch Children's Research Institute. Prior to access to any data the following would be required: a data access agreement must be signed by all relevant parties, the investigators of the study must see and approve the analysis plan describing how the data will be analysed. There must be also an agreement around appropriate acknowledgement in any future publications.
IPD Sharing Access Criteria
The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au

Learn more about this trial

Beat to Beat A Study in Paediatric, Adolescent and Young Adult Patients Who Are Undergoing or Have Undergone Cancer Therapy to Evaluate the Agreement Between QTc Measured Using 12 Lead Electrocardiogram (ECG) and a Wearable Device ECG

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