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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Childhood Cancer

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

External Links

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