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NCT05617391 Clinical Trial

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

Childhood Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05617391
Other study ID # WATCH4ECG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 13, 2022
Est. completion date June 2026

Study information
Verified date February 2024
Source St. Jude Children's Research Hospital
Contact Melissa Hudson, MD
Phone 866-278-5833
Email referralinfo@stjude.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1300
Est. completion date June 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (1)
Lead Sponsor Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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