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Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
RECRUITINGSponsored by Tulane University School of Medicine
Actively Recruiting
SponsorTulane University School of Medicine
Started2025-04-08
Est. completion2027-12
Eligibility
Age18 Years – 79 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04703166
Summary
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
Eligibility
Age: 18 Years – 79 YearsHealthy volunteers accepted
Inclusion Criteria: 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 Criteria: 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.
Conditions2
Atrial FibrillationHeart Disease
Locations1 site
Tulane University School of Medicine
New Orleans, Louisiana, 70112
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Actively Recruiting
SponsorTulane University School of Medicine
Started2025-04-08
Est. completion2027-12
Eligibility
Age18 Years – 79 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT04703166