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

NCT06753045 | Recruiting

• 1 other identifier: 2024-652
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Diseases

Keywords

Heart failure; Coronary artery disease; Stroke/TIA; Diabetes mellitus; Chronic kidney disease; Cardiac arrhythmias; Smart watch; Atrial fibrillation; A-fib; Artificial intelligence; Machine learning

Outcome Measures

Primary Outcomes (2)

• The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions

  These endpoints will be collected from the electronic health records using the International Classification of Diseases Tenth Edition (ICD-10) codes, prompted by a patient survey conducted via the use of a smart phone app. The investigators will use the the patient's survey answers as a prompt to check the EMR. If in the survey a patient mentions they had a cardiovascular incidence, then the EMR data will be checked to see the reports from the ER visit to confirm the incidence. The number that will be reported is the total number of cardiovascular incidences in each patient over the period of 1 year.

  1 Year

• The incidence of new cardiovascular diseases events

  These endpoints will be collected from the electronic health records using the International Classification of Diseases Tenth Edition (ICD-10) codes, prompted by a patient survey conducted via the use of a smart phone app. The investigators will use the the patient's survey answers as a prompt to check the EMR. If in the survey a patient mentions they had a cardiovascular incidence, then the EMR data will be checked to see the reports from the ER visit to confirm the incidence and check to confirm if the patient developed a new cardiovascular disease. The number that will be reported is the total number of cardiovascular incidences in each patient over the period of 1 year.

  1 Year

Study Arms (2)

Cohort arm

Patients with at least one cardiovascular disease, 9500 subjects.

Other: Smartwatch

Healthy arm

Patients visiting a primary care provider for any reason without any cardiovascular diseases, 500 subjects.

Other: Smartwatch

Interventions

Smartwatch OTHER

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

Cohort arm; Healthy arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include 10,000 patients older than 18 years who will either be healthy or with a pre-existing heart condition.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tulane University: lead
• Samsung Electronics: collaborator

Study Sites (3)

East Jefferson General Hospital

New Orleans, Louisiana, 70006, United States

RECRUITING

Tulane University Medical Group Clinics

New Orleans, Louisiana, 70112, United States

RECRUITING

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Heart Failure; Coronary Artery Disease; Diabetes Mellitus; Renal Insufficiency, Chronic; Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nassir Marrouche, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kunal Sameer, MD, MHA

CONTACT

504-988-3058; heartbeat@tulane.edu

Page E McKenzie, MS

CONTACT

504-988-3058; pmckenzie@tulane.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 31, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)