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 — DEVICE
    The 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 Fibrillation
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Tulane University School of MedicineNew OrleansLouisiana70112
Quintrele Jones, MPH
504-988-3063
Chris Wang, MS
504-988-3065
Nassir F Marrouche, MD (PRINCIPAL_INVESTIGATOR)

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