NCT04843371

PPG to Predict Ejection Fraction and Other Echographic Data in the General Population

Photoplethysmography (PPG) to Predict Ejection Fraction and Other Echographic Data in the General Population

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Tulane University · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

The investigators are aiming to investigate the association between ejection fraction (EF) determined by echocardiography and signals obtained from Photoplethysmography (PPG) in the general population. The investigators are also aiming to investigate the association between blood pressure and signals obtained from PPG in the general population. Finally, the investigators are also aiming to investigate the association between signals obtained from PPG in the general population to cardioechographic findings such as, valvular heart disease, structural heart diseases, cardiomyopathies, pericardial disease etc.

Detailed description

The investigators are proposing a cross-sectional cohort study, where any individual, 18 years old or older, scheduled for an echocardiography at Tulane University's outpatient cardiology clinic can be included. After consenting participants, information on their demographics, personal health habits, medications, and medical history will be collected via reviewing, their electronic medical health records. All participants will undergo an echocardiography as part of their routine medical care by their treating physician. Important echocardiographic findings will be noted such as, EF, valvular heart disease, pericardial disease, cardiomyopathies and structural heart disease. Additionally, PPG recordings will be collected simultaneously while performing echography using the Biostrap wristband. The investigators will analyze the association between each echographic imaging feature, and the PPG waveform obtained. PPG waveform features will be used to develop a predictive model capable of calculating an estimate of ventricular ejection fraction without echocardiography. All echocardiograms will be performed by experienced operators at Tulane Medical Center facilities. The study will occur at a single study site Tulane Medical Center and clinics, with appropriate facilities and equipment to conduct the study accurately and safely. An experienced echocardiogram technician or cardiology fellow will collect the PPG recordings using the Biostrap application. De-identified echocardiogram reports, including information on LVEF will be matched with the participant's pulse report.

Conditions

• Valvular Heart Disease
• Pericardial Disease
• Cardiomyopathies

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Photoplethysmography	Photoplethysmography (PPG) is a non-invasive technique that can detect volumetric changes in the peripheral blood. It only requires skin contact and relies on light absorption. PPG is a good indicator of the cardiovascular dynamics in the human body. PPG has been incorporated into various new smartphones and wearable devices such as, smartwatches and fitness wristbands making it readily available to all consumers. This sensor can record biometrics such as, heart rate, blood pressure, oxygen saturation, etc.

Timeline

• Start date: 2021-08-20
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-04-13
• Last updated: 2026-03-05

Locations

3 sites across 1 country: United States