Clinical trial · Interventional
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
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
NCT05615376CI-TRIAL-00087947completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiac Arrhythmia | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12 lead ECG | Device | — | UNRESOLVED |
| ECG application | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ECG App arm
- description
- Participants will be provided with a wearable device on Day 1 and Day 4 whilst admitted in hospital.
- interventionNames
- Device: ECG application
- Device: 12 lead ECG
Primary outcomes (4)
- measure
- Recording of a 12 lead ECG and wearable device ECG
- timeFrame
- Day 1 of inpatient stay
- 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.
- measure
- Recording of a 12 lead ECG and wearable device ECG
- timeFrame
- Day 4 of inpatient stay
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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 Exclusion Criteria: * Unable to wear the wearable device. * \< 18 years of age without guardian or parent to provide consent. * Interpreter required for consent purposes.
References
Publications (0)
Data not yet available
No reference posted for this study.