Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.

NCT04703166 | Recruiting

• 1 other identifier: 2849006
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Atrial Myopathy; Cardiovascular Risk Factors; Heart Murmurs; Arrhythmias; Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• Atrial Myopathy Progression

  To evaluate changes of atrial myopathy (via the extent of atrial fibrosis, the shape of left atrium \[LA\] and the function of the LA). This will be assessed via CMR scans.

  Based on results from CMR scan at baseline at 12-Months CMR scan

Secondary Outcomes (5)

• Heart Failure Incidence

  Through study completion, up to 52 weeks

• Cerebrovascular Incidence

  Through study completion, up to 52 weeks

• Hospitalization Incidence

  Through study completion, up to 52 weeks

• Arrhythmias Incidence

  Through study completion, up to 52 weeks

• Death Incidence

  Through study completion, up to 52 weeks

Study Arms (1)

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.

Device: Samsung Galaxy Watch Active2

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.

Participants with Atrial Fibrillation or have Moderate-high risk factors for Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years - 79 Years
• Gender Eligibility Details: Participant eligibility is based on the self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

360 participants, male or female with atrial fibrillation (18-79 years) or have moderate to high risk factors (40-79 years) for atherosclerotic cardiovascular disease as verified by the ASCVD risk estimator.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University School of Medicine: lead
• Samsung: collaborator
• Preventice: collaborator

Study Sites (1)

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

RECRUITING

Related Publications (7)

• Truong VT, Palmer C, Wolking S, Sheets B, Young M, Ngo TNM, Taylor M, Nagueh SF, Zareba KM, Raman S, Mazur W. Normal left atrial strain and strain rate using cardiac magnetic resonance feature tracking in healthy volunteers. Eur Heart J Cardiovasc Imaging. 2020 Apr 1;21(4):446-453. doi: 10.1093/ehjci/jez157.

  PMID: 31504357 BACKGROUND

• Bieging ET, Morris A, Wilson BD, McGann CJ, Marrouche NF, Cates J. Left atrial shape predicts recurrence after atrial fibrillation catheter ablation. J Cardiovasc Electrophysiol. 2018 Jul;29(7):966-972. doi: 10.1111/jce.13641. Epub 2018 Jun 19.

  PMID: 29846999 BACKGROUND

• Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.

  PMID: 24496537 BACKGROUND

• Cochet H, Mouries A, Nivet H, Sacher F, Derval N, Denis A, Merle M, Relan J, Hocini M, Haissaguerre M, Laurent F, Montaudon M, Jais P. Age, atrial fibrillation, and structural heart disease are the main determinants of left atrial fibrosis detected by delayed-enhanced magnetic resonance imaging in a general cardiology population. J Cardiovasc Electrophysiol. 2015 May;26(5):484-92. doi: 10.1111/jce.12651. Epub 2015 Apr 22.

  PMID: 25727248 BACKGROUND

• Siebermair J, Suksaranjit P, McGann CJ, Peterson KA, Kheirkhahan M, Baher AA, Damal K, Wakili R, Marrouche NF, Wilson BD. Atrial fibrosis in non-atrial fibrillation individuals and prediction of atrial fibrillation by use of late gadolinium enhancement magnetic resonance imaging. J Cardiovasc Electrophysiol. 2019 Apr;30(4):550-556. doi: 10.1111/jce.13846. Epub 2019 Jan 24.

  PMID: 30661270 BACKGROUND

• Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

  PMID: 31722151 BACKGROUND

• Majumder S, Mondal T, Deen MJ. Wearable Sensors for Remote Health Monitoring. Sensors (Basel). 2017 Jan 12;17(1):130. doi: 10.3390/s17010130.

  PMID: 28085085 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Heart Murmurs; Arrhythmias, Cardiac; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Nassir F Marrouche, MD

  Tulane University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quintrele Jones, MPH

CONTACT

504-988-3063; qjones1@tulane.edu

Chris Wang, MS

CONTACT

504-988-3065; hwang37@tulane.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: April 8, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)