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

NCT ID: NCT05617391

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-13

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Childhood Cancer Cardiomyopathy, Primary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric Childhood Cancer Survivors

The comparison of two ECGs in terms of predictive risk.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa Hudson, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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WATCH4ECG

Identifier Type: -

Identifier Source: org_study_id

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