Using smartwatches to collect health data for heart disease detection
Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology: HEARTBEAT
This study is testing whether wearing smartwatches can help gather health data to better understand and detect heart disease in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 3 sites (New Orleans, Louisiana and 2 other locations) |
| Trial ID | NCT06753045 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the use of smartwatches in collecting biometric data to enhance the understanding and detection of cardiovascular diseases. Up to 10,000 adult participants will wear a smartwatch for one year to gather digital biomarker data, while also completing questionnaires through a decentralized platform. The study focuses on identifying patterns in biometric signals that may indicate an increased risk of heart diseases, leveraging advanced analytics and machine learning for data analysis. There are no drugs or interventions involved, as the study is purely observational.
Who should consider this trial
Good fit: Ideal candidates include adults with cardiovascular diseases or those visiting primary care providers without such conditions.
Not a fit: Patients who cannot comply with the use of wearable devices or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of cardiovascular diseases through continuous biometric monitoring.
How similar studies have performed: Other studies utilizing wearable technology for health monitoring have shown promise, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with at least one cardiovascular disease (heart failure, cardiac arrhythmias, chronic kidney disease, coronary artery disease, history of stroke/Transient Ischemic Attack (TIA), or diabetes mellitus). * Patients visiting a primary care provider for any reason without any of the previously mentioned cardiovascular diseases. (Healthy cohort, limited up to 500 patients throughout the study). Exclusion Criteria: * Participants who cannot read, speak, and/or understand English. * Participants with cognitive impairments who are unable to give informed consent or sign their HIPAA form. * Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices. * Participants who are pregnant. * Participants with tattoos, scars, or skin adhesions that would not allow for Photoplethysmography (PPG) recordings to be collected from a wrist-worn device. * Participants with neurological disorders that may interfere with device signal quality (e.g., hand tremors). * Participants with a pacemaker. * Participants with allergies to watch and/or wristband materials. * Participants with known plans to permanently leave the state of Louisiana within the observational period. * Participants who have no known medical history with any of the enrolling institutions. * Patients without a compatible smartphone (iOS 13 \& Android 11 at minimum).
Where this trial is running
New Orleans, Louisiana and 2 other locations
- East Jefferson General Hospital — New Orleans, Louisiana, United States (Recruiting)
- Tulane University Medical Group Clinics — New Orleans, Louisiana, United States (Recruiting)
- University Medical Center — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Nassir Marrouche, MD — Tulane University
- Study coordinator: Kunal Sameer, MD, MHA
- Email: heartbeat@tulane.edu
- Phone: 504-988-3058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.