Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.

Summary

Participation Requirements

Description

The purpose of the TiPP study is to correlate atrial myopathy with biometric findings from wearable devices (Samsung Smart watch and Electrocardiogram (ECG) patches from Preventice) in Atrial Fibrillation (AF) patients and in individuals with moderate to high-risk factors for Cardiovascular Diseases...

The purpose of the TiPP study is to correlate atrial myopathy with biometric findings from wearable devices (Samsung Smart watch and Electrocardiogram (ECG) patches from Preventice) in Atrial Fibrillation (AF) patients and in individuals with moderate to high-risk factors for Cardiovascular Diseases (CVD) and via cardiac magnetic resonance imaging (CMR). A total of 300 participants will be enrolled who either have AF or have moderate-high risk factors for CVD as defined by the Atherosclerotic Vascular Disease (ASCVD) Risk Estimator Score. Enrolled participants will be between the ages of 18 to 79 years of age. At the first study visit, each participant will undergo a baseline CMR scan. At this visit, a study coordinator will provide them with a Samsung Galaxy Watch Active 2, Samsung Galaxy phone S9 and patches. Application set-up on their mobile device and compatibility will be assessed. Participants will be followed for their daily biometric data for one year via Samsung's Galaxy Watch Active 2 and will be asked to wear an ECG wearable patch, every 3 months for 30-days for arrhythmia detection and assessment. (Baseline, 6, 9 and 12 months) Phone call visits will occur at 6 and 9 months to monitor for watch and patch compliance as well as to assess that all devices are working accordingly. Monitoring participants and reviewing their medical history for any AF recurrences will also be recorded during this visit. At the 12-month follow-up visit, the final CMR will be repeated to assess for changes in LA fibrosis/shape/function and will be compared and contrasted to the daily biometric data. In addition, the PPG waveform recordings (Samsung's Galaxy Watch Active 2) will also be compared and contrasted to collected ECG strips to evaluate for the capability of a continuous PPG tachogram to detect AF+/recurrences. The study will help identify modifiable risk factors by accurately assessing daily biometric data and its correlation with cardiac structural and fibrotic changes as well as cardiovascular outcomes. These new predictors will allow for better anticipation of future heart disease incidence and/ or progression. In addition, daily biometric health data will be used to train a machine learning concept, by means of a continuous tachogram which will predict atrial myopathy and major cardiovascular outcomes, leading to earlier preventive interventions.

Tracking Information