TiPP: Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
Study Details
Study Description
Brief Summary
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The purpose of the TiPP study is to correlate atrial myopathy with biometric findings from wearable devices (Samsung Smart watch and Electrocardiogram (ECG) patches from Preventice) in Atrial Fibrillation (AF) patients and in individuals with moderate to high-risk factors for Cardiovascular Diseases (CVD) and via cardiac magnetic resonance imaging (CMR).
A total of 300 participants will be enrolled who either have AF or have moderate-high risk factors for CVD as defined by the Atherosclerotic Vascular Disease (ASCVD) Risk Estimator Score. Enrolled participants will be between the ages of 18 to 79 years of age.
At the first study visit, each participant will undergo a baseline CMR scan. At this visit, a study coordinator will provide them with a Samsung Galaxy Watch Active 2, Samsung Galaxy phone S9 and patches. Application set-up on their mobile device and compatibility will be assessed.
Participants will be followed for their daily biometric data for one year via Samsung's Galaxy Watch Active 2 and will be asked to wear an ECG wearable patch, every 3 months for 30-days for arrhythmia detection and assessment. (Baseline, 6, 9 and 12 months)
Phone call visits will occur at 6 and 9 months to monitor for watch and patch compliance as well as to assess that all devices are working accordingly. Monitoring participants and reviewing their medical history for any AF recurrences will also be recorded during this visit.
At the 12-month follow-up visit, the final CMR will be repeated to assess for changes in LA fibrosis/shape/function and will be compared and contrasted to the daily biometric data.
In addition, the PPG waveform recordings (Samsung's Galaxy Watch Active 2) will also be compared and contrasted to collected ECG strips to evaluate for the capability of a continuous PPG tachogram to detect AF+/recurrences.
The study will help identify modifiable risk factors by accurately assessing daily biometric data and its correlation with cardiac structural and fibrotic changes as well as cardiovascular outcomes. These new predictors will allow for better anticipation of future heart disease incidence and/ or progression. In addition, daily biometric health data will be used to train a machine learning concept, by means of a continuous tachogram which will predict atrial myopathy and major cardiovascular outcomes, leading to earlier preventive interventions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Active2 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
The Samsung wearable device will collect data; photoplethysmography (PPG) waveforms, heart rate, heart rate variability, step counts, oxygen saturation levels, sleep pattern and quality.
|
Outcome Measures
Primary Outcome Measures
- Atrial Myopathy Progression [Based on results from CMR scan at baseline at 12-Months CMR scan]
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.
Secondary Outcome Measures
- Heart Failure Incidence [Through study completion, up to 52 weeks]
During the 6 month and 9 month phone call visits, we will ask the participants if they have had any incidence of heart failure.
- Cerebrovascular Incidence [Through study completion, up to 52 weeks]
During the 6 month and the 9 month phone call visits, we will ask the participants if they have had any clinically relevant cerebrovascular events such as stroke and/or Transient Ischemic Attack (TIA).
- Hospitalization Incidence [Through study completion, up to 52 weeks]
During the 6 month and the 9 month phone call visits, we will ask the participants if they have had any cardiac related hospitalization.
- Arrhythmias Incidence [Through study completion, up to 52 weeks]
During the 6 month and the 9 month phone call visits, we will ask the participants if they have had any incidence of any cardiac arrhythmias.
- Death Incidence [Through study completion, up to 52 weeks]
During the 6 month and the 9 month phone call visits, we will check for mortality.
Eligibility Criteria
Criteria
Inclusion Criteria:
Participants must meet the following criteria to be enrolled in the trial:
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Participants with atrial fibrillation aged 18 to 79 years old, or
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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.
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Participants who have access to internet/e-mail in their homes.
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Participants who have access to a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
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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.
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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:
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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.).
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Participants weighing >300 lbs. (MRI quality decreases as BMI increases).
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Participants with renal insufficiency (Glomerular Filtration Rate (GFR) <30 mL per minute per 1.73 m2) or acute/severe renal dysfunction/disease.
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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).
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Participants who do not have access to the internet/e-mail.
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Participants who do not have a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
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Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.
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Participants who are unable or unwilling to return to the study clinic one-year post baseline for their follow-up appointment and CMR.
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Participants with cognitive impairments who are unable to give informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
Sponsors and Collaborators
- Tulane University School of Medicine
- Samsung
- Preventice
Investigators
- Principal Investigator: Nassir F Marrouche, MD, Tulane University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Cochet H, Mouries A, Nivet H, Sacher F, Derval N, Denis A, Merle M, Relan J, Hocini M, Haïssaguerre M, Laurent F, Montaudon M, Jaïs 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.
- Majumder S, Mondal T, Deen MJ. Wearable Sensors for Remote Health Monitoring. Sensors (Basel). 2017 Jan 12;17(1). pii: E130. doi: 10.3390/s17010130. Review.
- 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. Erratum in: JAMA. 2014 Nov 5;312(17):1805.
- 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.
- 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.
- 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.
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