Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Tulane University
Study ID
NCT06753045
Status
Recruiting
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Conditions

  • Heart Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Accepted

Interventions

  • Smartwatch — OTHER
    Sensors on the smartwatch will measure vitals such as heart rate, blood pressure, oxygen saturation, body composition, and electrocardio gram (ECG)

Study Details

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.

Key Dates

Start date
Oct 8, 2024
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: Cohort arm
    Patients with at least one cardiovascular disease, 9500 subjects.
  • Arm: Healthy arm
    Patients visiting a primary care provider for any reason without any cardiovascular diseases, 500 subjects.

Primary Outcome Measure

The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions [ Time Frame: 1 Year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
East Jefferson General HospitalNew OrleansLouisiana70006
Kunal Sameer, MD, MHA
[email protected]
504-988-3058
Page E McKenzie, MS
[email protected]
504-988-3058
Nassir Marrouche, MD (PRINCIPAL_INVESTIGATOR)
Tulane University Medical Group ClinicsNew OrleansLouisiana70112
Kunal Sameer, MD, MHA
[email protected]
504-988-3058
Page E McKenzie, MS
[email protected]
504-988-3058
Nassir Marrouche, MD (PRINCIPAL_INVESTIGATOR)
University Medical CenterNew OrleansLouisiana70112
Kunal Sameer, MD, MHA
[email protected]
504-988-3058
Page E McKenzie, MS
[email protected]
504-988-3058
Nassir Marrouche, MD (PRINCIPAL_INVESTIGATOR)

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By research site
East Jefferson General Hospital· New Orleans, LATulane University Medical Group Clinics· New Orleans, LAUniversity Medical Center· New Orleans, LA

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