Evaluating heart aging and atrial myopathy using wearable devices
Tulane iPredict, Prevent (TiPP) Study
This study is testing how wearable devices can help track heart health and aging in people with atrial myopathy over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 1 site (New Orleans, Louisiana) |
| Trial ID | NCT04703166 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 79 with atrial fibrillation or those aged 40 to 79 at moderate to high risk for cardiovascular disease.
Not a fit: Patients with health-related contraindications to MRI or those without access to compatible mobile devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and prevention of heart diseases in diverse patient populations.
How similar studies have performed: Other studies utilizing wearable technology for cardiovascular monitoring have shown promise, indicating a potential for success in this innovative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Orleans, Louisiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.