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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05615376




Registration number
NCT05615376
Ethics application status
Date submitted
7/11/2022
Date registered
14/11/2022

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
88476
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Cardiac Arrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ECG application
Treatment: Devices - 12 lead ECG

Experimental: ECG App arm - Participants will be provided with a wearable device on Day 1 and Day 4 whilst admitted in hospital.


Treatment: Devices: ECG application
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.

Treatment: Devices: 12 lead ECG
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recording of a 12 lead ECG and wearable device ECG
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Day 1 of inpatient stay
Primary outcome [2] 0 0
Recording of a 12 lead ECG and wearable device ECG
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Day 4 of inpatient stay
Primary outcome [3] 0 0
Calculation of QT interval by two blinded health professionals
Assessment method [3] 0 0
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).
Timepoint [3] 0 0
Day 1 of inpatient stay
Primary outcome [4] 0 0
Calculation of QT interval by two blinded health professionals
Assessment method [4] 0 0
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).
Timepoint [4] 0 0
Day 4 of inpatient stay
Secondary outcome [1] 0 0
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Day 1 inpatient stay
Secondary outcome [2] 0 0
Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Day 4 inpatient stay
Secondary outcome [3] 0 0
Sensitivity calculations of wearable device vs 12 Lead ECG
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Day 1 inpatient stay
Secondary outcome [4] 0 0
Sensitivity calculations of wearable device vs 12 Lead ECG
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Day 4 inpatient stay
Secondary outcome [5] 0 0
Specificity calculations of wearable device vs 12 Lead ECG
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Day 1 inpatient stay
Secondary outcome [6] 0 0
Specificity calculations of wearable device vs 12 Lead ECG
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Day 4 inpatient stay
Secondary outcome [7] 0 0
To calculate the interobserver variability between the two health care professional readings of QTc.
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Day 1 inpatient stay
Secondary outcome [8] 0 0
To calculate the interobserver variability between the two health care professional readings of QTc.
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
Day 4 inpatient stay

Eligibility
Key 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:

1. iPhone (6s or later) with iOS version 15.0 or later defined as iPhone model/iOS version used to complete screening eligibility.
2. Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone.
3. Valid phone number associated with iPhone, ascertained from self-report.
4. Valid email address, ascertained from self-report.
5. Participants or parents need to be able to press down on the wearable device crown for 30 seconds
Minimum age
7 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to wear the wearable device.
* < 18 years of age without guardian or parent to provide consent.
* Interpreter required for consent purposes.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/03/2025
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
A/Prof Rachel Conyers
Address 0 0
The Royal Children's Hospital/Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lane Collier
Address 0 0
Country 0 0
Phone 0 0
03 9936 6324
Email 0 0
acor@mcri.edu.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05615376