An Evaluation of Concordance of Smartwatch ECG and One Clinical ECG and Comparison of The Two ECGS in Terms of Predictive Risks

April 22, 2026 updated by: St. Jude Children's Research Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The proposed study is looking to compare the 30 second ECG read from a smartwatch to the clinical ECG during a SJLIFE scheduled ECG appointment.

Study Type

Observational

Enrollment (Actual)

1303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study.

Description

Inclusion Criteria:

  • SJLIFE participant and 22 years of age or older at time of enrollment
  • Participant or legal guardian is able and willing to give informed consent
  • At least 5 years after childhood cancer diagnosis

Exclusion Criteria:

  • Been diagnosed with cardiomyopathy on previous SJLIFE ECG
  • Currently on heart medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Pediatric Childhood Cancer Survivors
The comparison of two ECGs in terms of predictive risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard 12-lead ECG
Time Frame: Baseline
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
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Melissa Hudson, MD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2022

Primary Completion (Actual)

January 17, 2025

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WATCH4ECG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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