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Trial Title:
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
Condition:
Childhood Cancer
Cardiomyopathy, Primary
Conditions: Official terms:
Cardiomyopathies
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Detailed 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.
Criteria for eligibility:
Study pop:
All participants who meet eligibility criteria and consent to enrollment on the study.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
22 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melissa Hudson, MD
Phone:
866-278-5833
Email:
referralinfo@stjude.org
Investigator:
Last name:
Melissa Hudson, MD
Email:
Principal Investigator
Start date:
December 13, 2022
Completion date:
June 2026
Lead sponsor:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Source:
St. Jude Children's Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05617391
http://www.stjude.org
http://www.stjude.org/protocols
