Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy. (NCT04703166) | Clinical Trial Compass
RecruitingNot Applicable
Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
United States360 participantsStarted 2025-04-08
Plain-language summary
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
Who can participate
Age range18 Years – 79 Years
SexALL
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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 d…
What they're measuring
1
Atrial Myopathy Progression
Timeframe: Based on results from CMR scan at baseline at 12-Months CMR scan