NCT04703166 Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
| NCT ID | NCT04703166 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulane University School of Medicine |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 360 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 360 participants in total. It began in 2025-04-08 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
Eligibility 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.
Contact & Investigator
Nassir F Marrouche, MD
PRINCIPAL INVESTIGATOR
Tulane University School of Medicine
Frequently Asked Questions
Who can join the NCT04703166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04703166 currently recruiting?
Yes, NCT04703166 is actively recruiting participants. Contact the research team at qjones1@tulane.edu for enrollment information.
Where is the NCT04703166 trial being conducted?
This trial is being conducted at New Orleans, United States.
Who is sponsoring the NCT04703166 clinical trial?
NCT04703166 is sponsored by Tulane University School of Medicine. The principal investigator is Nassir F Marrouche, MD at Tulane University School of Medicine. The trial plans to enroll 360 participants.
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