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

Official title

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

Overview

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.

Detailed description

The central hypothesis in the HEARTBEAT project posits that cardiovascular events are preceded by abnormalities in biometric signals obtained from a smartwatch. These abnormalities may include, but are not limited to, patterns of heart rate, heart rate variability, oxygen saturation, as well as raw PPG signals. By leveraging advanced analytics and machine learning algorithms on smartwatch-derived biometric data, the investigators plan to identify patterns and markers that signal an increased cardiovascular disease risk.

The study will use an end-to-end decentralized approach for data collection. Huma and Alcedis, the electronic data capture (EDC) agencies, will act as the data storage facilitator for 10,000 eligible subjects. The Principal Investigators (PIs) and trained site staff members will assess healthy subjects based on their clinical opinion. If the subjects meet the eligibility criteria and are interested in participating, they will be consented by Tulane.

During the study enrollment phase, a smartwatch will be provided to the subjects, who will then be trained on the study procedures, the web-based questionnaire, and the use of the wearable device. The subjects will be asked to wear the device for one year, after which they will return it to Tulane.

Interventions

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

Primary outcome measures

• The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions [Time frame: 1 Year]
• The incidence of new cardiovascular diseases events [Time frame: 1 Year]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

United States · 3 centers

• East Jefferson General Hospital — New Orleans
• Tulane University Medical Group Clinics — New Orleans
• University Medical Center — New Orleans

Identifiers

NCT: NCT06753045 · 2024-652

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗