NOT_YET_RECRUITING
Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
Conditions:
🦠 Atrial Fibrillation
🗓️ Study Start (Actual) August 2024
🗓️ Primary Completion (Estimated) December 2026
✅ Study Completion (Estimated) December 2026
👥 Enrollment (Estimated) 300
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 New Orleans, Louisiana, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 79 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 January 2021
  • First Submitted that Met QC Criteria 7 January 2021
  • First Posted 11 January 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 July 2024
  • Last Update Posted 5 July 2024
  • Last Verified July 2024