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

NCT05617391 | Active Not Recruiting

• 1 other identifier: WATCH4ECG
• Study Type: observational
• Target: 1,303
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Cancer; Cardiomyopathy, Primary

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Pediatric Childhood Cancer Survivors

The comparison of two ECGs in terms of predictive risk.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neoplasms; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Melissa Hudson, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: December 13, 2022
• Primary Completion: January 17, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)