Status:
RECRUITING
Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
Lead Sponsor:
Tulane University School of Medicine
Collaborating Sponsors:
Samsung
Preventice
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-79 years
Brief Summary
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
Detailed Description
The Tulane iPredict Prevent (TiPP) project aims to study the aging of the heart in a diverse patient population using wearable digital health devices with the help of Samsung and Boston Scientific. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04703166
Start Date
April 8 2025
End Date
December 1 2027
Last Update
April 17 2025
Active Locations (1)
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1
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112