Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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
Query!
Secondary ID [1]
0
0
88476
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Neoplasms
0
0
Query!
Cardiac Arrhythmia
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Recording of a 12 lead ECG and wearable device ECG
Query!
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.
Query!
Timepoint [1]
0
0
Day 1 of inpatient stay
Query!
Primary outcome [2]
0
0
Recording of a 12 lead ECG and wearable device ECG
Query!
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.
Query!
Timepoint [2]
0
0
Day 4 of inpatient stay
Query!
Primary outcome [3]
0
0
Calculation of QT interval by two blinded health professionals
Query!
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).
Query!
Timepoint [3]
0
0
Day 1 of inpatient stay
Query!
Primary outcome [4]
0
0
Calculation of QT interval by two blinded health professionals
Query!
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).
Query!
Timepoint [4]
0
0
Day 4 of inpatient stay
Query!
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
Query!
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.
Query!
Timepoint [1]
0
0
Day 1 inpatient stay
Query!
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
Query!
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.
Query!
Timepoint [2]
0
0
Day 4 inpatient stay
Query!
Secondary outcome [3]
0
0
Sensitivity calculations of wearable device vs 12 Lead ECG
Query!
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.
Query!
Timepoint [3]
0
0
Day 1 inpatient stay
Query!
Secondary outcome [4]
0
0
Sensitivity calculations of wearable device vs 12 Lead ECG
Query!
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.
Query!
Timepoint [4]
0
0
Day 4 inpatient stay
Query!
Secondary outcome [5]
0
0
Specificity calculations of wearable device vs 12 Lead ECG
Query!
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.
Query!
Timepoint [5]
0
0
Day 1 inpatient stay
Query!
Secondary outcome [6]
0
0
Specificity calculations of wearable device vs 12 Lead ECG
Query!
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.
Query!
Timepoint [6]
0
0
Day 4 inpatient stay
Query!
Secondary outcome [7]
0
0
To calculate the interobserver variability between the two health care professional readings of QTc.
Query!
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.
Query!
Timepoint [7]
0
0
Day 1 inpatient stay
Query!
Secondary outcome [8]
0
0
To calculate the interobserver variability between the two health care professional readings of QTc.
Query!
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.
Query!
Timepoint [8]
0
0
Day 4 inpatient stay
Query!
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
Query!
Minimum age
7
Years
Query!
Query!
Maximum age
18
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Diagnosis
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
7/02/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2024
Query!
Actual
Query!
Sample size
Target
46
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
The Royal Children's Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
3052 - Parkville
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Murdoch Childrens Research Institute
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05615376
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
A/Prof Rachel Conyers
Query!
Address
0
0
The Royal Children's Hospital/Murdoch Children's Research Institute
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Lane Collier
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
03 9936 6324
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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
[email protected]
.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
Query!
When will data be available (start and end dates)?
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.
Query!
Available to whom?
The data may be obtained from the Murdoch Children's Research Institute by emailing
[email protected]
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
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