|

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

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
Quintrele Jones, MPH504-988-3063qjones1@tulane.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.