NCT06753045 Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology
| NCT ID | NCT06753045 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulane University |
| Condition | Heart Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2024-10-08 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase 0, non-interventional, longitudinal, electronic data capture (EDC) study to facilitate the HEARTBEAT Study project has set out to explore the potential use of smartwatches in collecting and analyzing biometric data to improve the detection, identification, and understanding of cardiovascular diseases and related conditions by SAMSUNG and Tulane. The study will include up to ten thousand adult subjects tasked with wearing a smartwatch to collect digital biomarker data over a 1 year period. Concurrent to smartwatch data collection, subjects will be instructed to complete questionnaires via the Huma Decentralized Clinical Trials (HUMADCT) platform. There are no investigational drugs or interventions administered as part of this study.
Eligibility 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).
Contact & Investigator
Nassir Marrouche, MD
PRINCIPAL INVESTIGATOR
Tulane University
Frequently Asked Questions
Who can join the NCT06753045 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Heart Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06753045 currently recruiting?
Yes, NCT06753045 is actively recruiting participants. Contact the research team at heartbeat@tulane.edu for enrollment information.
Where is the NCT06753045 trial being conducted?
This trial is being conducted at New Orleans, United States, New Orleans, United States, New Orleans, United States.
Who is sponsoring the NCT06753045 clinical trial?
NCT06753045 is sponsored by Tulane University. The principal investigator is Nassir Marrouche, MD at Tulane University. The trial plans to enroll 10,000 participants.