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

NCT05615376 | Completed DMC

• 1 other identifier: 88476
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Cardiac Arrhythmia

Keywords

QT prolongation; cancer; paediatric; ECG application; 12 lead ECG

Outcome Measures

Primary Outcomes (4)

• 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.

  Day 1 of inpatient stay

• 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.

  Day 4 of inpatient stay

• 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).

  Day 1 of inpatient stay

• 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).

  Day 4 of inpatient stay

Secondary Outcomes (8)

• Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG

  Day 1 inpatient stay

• Number of Participants with Abnormal QTc that is greater than 0.48mm on 12 lead ECG and wearable device ECG

  Day 4 inpatient stay

• Sensitivity calculations of wearable device vs 12 Lead ECG

  Day 1 inpatient stay

• Sensitivity calculations of wearable device vs 12 Lead ECG

  Day 4 inpatient stay

• Specificity calculations of wearable device vs 12 Lead ECG

  Day 1 inpatient stay

Study Arms (1)

ECG App arm

EXPERIMENTAL

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

Device: ECG application; Device: 12 lead ECG

Interventions

ECG application DEVICE

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.

ECG App arm

12 lead ECG DEVICE

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.

ECG App arm

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unable to wear the wearable device.
• \< 18 years of age without guardian or parent to provide consent.
• Interpreter required for consent purposes.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

The Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Neoplasms; Arrhythmias, Cardiac; Long QT Syndrome

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• A/Prof Rachel Conyers

  The Royal Children's Hospital/Murdoch Children's Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: February 7, 2023
• Primary Completion: June 30, 2024
• Study Completion: March 17, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au

Locations

AU (1)