RecruitingNCT04703166

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

Tulane iPredict, Prevent (TiPP) Study

Sponsor

Tulane University School of Medicine

Enrollment

360 participants

Start Date

Apr 8, 2025

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation

Summary

To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.

Eligibility

Min Age: 18 YearsMax Age: 79 Years

Inclusion Criteria7

Participants must meet the following criteria to be enrolled in the trial:
Participants with atrial fibrillation aged 18 to 79 years old, or
Participants aged 40 to 79 years old, at moderate or high risk for CVD as defined by the 10-year risk Atherosclerotic Cardiovascular Disease (ASCVD), a validated risk calculation tool.
Participants who have access to internet/e-mail in their homes.
Participants who have access to a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
Participants who are able and willing to return to the study clinic one-year following their baseline CMR for a follow-up appointment and 12-month CMR.
Participants who are able to read, understand, and sign the consent form.

Exclusion Criteria10

Participants will be excluded from enrollment if any of the following criteria are present:
Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.).
Participants weighing \>300 lbs. (MRI quality decreases as BMI increases).
Participants with renal insufficiency (Glomerular Filtration Rate (GFR) \<30 mL per minute per 1.73 m2) or acute/severe renal dysfunction/disease.
Women who are pregnant at the time of enrollment/consent. (Should a participant become pregnant during the course of the study, no CMR will be performed until 10 days, postpartum).
Participants who do not have access to the internet/e-mail.
Participants who do not have a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.
Participants who are unable or unwilling to return to the study clinic one-year post baseline for their follow-up appointment and CMR.
Participants with cognitive impairments who are unable to give informed consent.

Interventions

DEVICESamsung Galaxy Watch Active2

The Samsung wearable device will collect data; photoplethysmography (PPG) waveforms, heart rate, heart rate variability, step counts, oxygen saturation levels, sleep pattern and quality.