Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy. (TiPP)
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| ClinicalTrials.gov Identifier: NCT04703166 |
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Recruitment Status :
Not yet recruiting
First Posted : January 11, 2021
Last Update Posted : November 17, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Atrial Fibrillation | Device: Samsung Galaxy Watch Active2 |
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 Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Tulane iPredict, Prevent (TiPP) Study |
| Estimated Study Start Date : | January 2022 |
| Estimated Primary Completion Date : | February 2023 |
| Estimated Study Completion Date : | February 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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. |
- Atrial Myopathy Progression [ Time Frame: 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.
- Heart Failure Incidence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through study completion, up to 52 weeks ]During the 6 month and the 9 month phone call visits, we will check for mortality.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Participant eligibility is based on the self-representation of gender identity. |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04703166
| Contact: Arezu Bhatnagar (Medical Monitor), MD MSCRM BSc | 504-988-6203 | abhatnagar@tulane.edu | |
| Contact: Agnieszka Jezierska-Drutel (Study Coordinator), PhD | 504-988-6443 | ajezierskadrutel@tulane.edu |
| United States, Louisiana | |
| Tulane University School of Medicine | |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Arezu Bhatnagar, MD MSCRM BSc 504-988-6203 abhatnagar@tulane.edu | |
| Contact: Agnieszka Jezierska-Drutel, PhD 504-988-6443 ajezierskadrutel@tulane.edu | |
| Principal Investigator: Nassir F Marrouche, MD | |
| Principal Investigator: | Nassir F Marrouche, MD | Tulane University School of Medicine |
| Responsible Party: | Tulane University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT04703166 |
| Other Study ID Numbers: |
2849006 |
| First Posted: | January 11, 2021 Key Record Dates |
| Last Update Posted: | November 17, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Atrial Fibrillation Atrial Myopathy Cardiovascular Risk Factors |
Heart Murmurs Arrhythmias Cardiac Disease |
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |