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

December 20, 2023 updated by: Tulane University School of Medicine

Tulane iPredict, Prevent (TiPP) Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The Tulane iPredict Prevent (TiPP) project aims to study the aging of the heart in a diverse patient population using wearable digital health devices with the help of Samsung and Boston Scientific.

The innovative project seeks to correlate aging of the heart with daily biometric data obtained from wearable digital health devices, using Samsung's Galaxy Watch 3. Participants' biometric data, which include heart rate, step count, sleep patterns, and more, along with ECG readings from Preventice (Boston Scientific) Body Guardian Mini, will inform a machine learning model, providing real-time risk assessment of cardiovascular events.

In addition to monitoring biometric data, participants will undergo advanced cardiac imaging (CMR) scans at baseline and one-year follow-up to evaluate markers of aging of the heart (atrial myopathy). These scans, paired with the continuous data from the wearable devices, will offer a detailed understanding of the progression of atrial myopathy over time.

The TiPP study's unique approach of leveraging digital health technology represents an exciting innovation in cardiovascular research. This study's findings are expected to revolutionize our understanding of heart aging and, more importantly, the prediction and prevention of heart diseases in diverse patient populations.

Moreover, the study outcomes will allow us to accurately assess the clinical relevance of daily biometric data, leading to improved and personalized care. The insights gathered will be pivotal in informing early preventive interventions, significantly improving patient outcomes and transforming how we approach cardiovascular diseases and arrhythmias.

The primary outcome of the study will be evaluating the progression of atrial myopathy based on CMR scans. Meanwhile, secondary outcomes will include the incidence of heart failure, stroke, hospitalization, arrhythmias, and mortality during the study period.

With the increasing prevalence of cardiovascular diseases globally, the TiPP study, with its novel use of technology and inclusive approach, stands at the forefront of heart disease research, potentially altering the course of cardiovascular treatment and management.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
        • Principal Investigator:
          • Nassir F Marrouche, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

300 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Based on results from CMR scan at baseline at 12-Months CMR scan

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, up to 52 weeks
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).
Through study completion, up to 52 weeks
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.
Through study completion, up to 52 weeks
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.
Through study completion, up to 52 weeks
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.
Through study completion, up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University School of Medicine

Collaborators

Preventice
Samsung

Investigators

  • Principal Investigator: Nassir F Marrouche, MD, Tulane University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2849006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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