Evaluating heart aging and atrial myopathy using wearable devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Tulane iPredict Prevent project aims to study the progression of atrial myopathy by utilizing wearable digital health devices and advanced cardiac imaging. Participants will wear Samsung Galaxy Watches to collect daily biometric data, including heart rate and sleep patterns, which will be analyzed alongside ECG readings from the Preventice Body Guardian Mini. This data will inform a machine learning model for real-time cardiovascular risk assessment. Additionally, participants will undergo cardiac imaging scans at the start and after one year to evaluate heart aging markers, providing insights into the relationship between daily health metrics and atrial myopathy progression.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tulane University School of Medicine
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Nassir F Marrouche, MD — Tulane University School of Medicine
• Study coordinator: Quintrele Jones, MPH
• Email: qjones1@tulane.edu
• Phone: 504-988-3063

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.