Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
Part of paid clinical trials in New Orleans, Louisiana.
- Sponsor
- Tulane University School of Medicine
- Study ID
- NCT04703166
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 79 Years
- Healthy Volunteers
- Not accepted
Interventions
- Samsung Galaxy Watch Active2 — DEVICEThe Samsung wearable device will collect data; photoplethysmography (PPG) waveforms, heart rate, heart rate variability, step counts, oxygen saturation levels, sleep pattern and quality.
Study Details
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
Key Dates
- Start date
- Apr 8, 2025
- Status verified
- May 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 360 participants (estimated)
Arms
- Arm: Participants with Atrial Fibrillation or have Moderate-high risk factors for Atrial FibrillationParticipants who have atrial fibrillation or have moderate to high-risk factors for the development of atrial fibrillation as verified by the Atherosclerotic CardioVascular Disease (ASCVD) risk calculation tool. Participants will be provided with a Samsung Galaxy Watch to wear daily and will also be asked to wear an ECG patch for 30-days at baseline, 6, 9 and 12 months. A Cardiac MRI (CMR) will be taken at baseline and at 12 months.
Primary Outcome Measure
Atrial Myopathy Progression [ Time Frame: Based on results from CMR scan at baseline at 12-Months CMR scan ]
Central Contacts
- Quintrele Jones, MPH504-988-3063
- Chris Wang, MS504-988-3065
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | Nassir F Marrouche, MD (PRINCIPAL_INVESTIGATOR) |
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