NCT05617391|Active Not Recruiting
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Sponsor study identifier
observational
1,303
1 country
1
Study Start
December 13, 2022
Actual (reported)Primary Completion
January 17, 2025
Actual (reported)Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The participant is being asked to take part in this trial, because the participant is a survivor of childhood cancer. Primary Objective To evaluate remote cardiomyopathy prediction via smartwatch and one clinical ECG and assess the concordance of the two ECGs in terms of predicted risk. Secondary Objective To build a novel predictive model solely on smartwatch ECG to predict risk for cardiomyopathy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2022
Actual (reported)November 15, 2022
Actual (reported)December 13, 2022
Actual (reported)January 17, 2025
Actual (reported)June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Standard 12-lead ECG
To be obtained during SLIFE Human Performance Lab appointment. Participant will receive a resting (supine) 12-lead ECG using a GE Mac 2000 Resting ECG System (General Electric Healthcare, Milwaukee, WI, USA). This will be assessed with the Apple Smartwatch ECG recording to determine concordance of the two ECGs.
Baseline
Apple Smartwatch ECG 30-second recording
To be obtained during the SLIFE Human Performance Lab appointment, collected immediately after recording of the standard 12-lead ECG. A study team member will place an Apple Smartwatch Series 7 on the participant's wrist. The participant will be instructed to start the ECG, which will be a 30-second recording process. Once captured, the data will be automatically transferred to the IOS application on the study iPhone. This will be assessed with the standard 12-lead ECG recording to determine concordance of the two ECGs.
Baseline
The comparison of two ECGs in terms of predictive risk.
All participants who meet eligibility criteria and consent to enrollment on the study.
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Melissa Hudson, MD
St. Jude Children's Research Hospital
1,303 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2022
First Posted
November 15, 2022
Study Start
December 13, 2022
Actual (reported)Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience
Contact the study team to confirm eligibility.
Primary Completion
January 17, 2025
Actual (reported)Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 23, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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