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

N/AActive Not RecruitingNCT05617391

St. Jude Children's Research Hospital1,303 enrolled

Overview

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.

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

1,303

Conditions

Childhood Cancer Cardiomyopathy, Primary

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Jude Children's Research Hospital

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline