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NCT Number: NCT04843371

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

East Jefferson General Hospital, New Orleans, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female aged18 years or older.
  • Patients scheduled to undergo an echocardiogram at Tulane Medical Center.

Exclusion criteria

  • Participants under 18 years of age.
  • Participants with cognitive impairments.
  • Participants with a physical inability to wear the Biostrap during the echocardiogram.
  • Individuals who cannot read, speak, and/or understand English.

Treatment and study plan

Photoplethysmography

Diagnostic Test

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.

Primary outcomes

  1. Association between obtained PPG waveforms and recorded ejection (EF) fractions.

    Time frame: Day 1

    Patients who will undergo echocardiogram will wear the biostrap watch and then the PPG waveform will be obtained. Then, the ejection fraction will be collected from the echocardiogram report. Then, the Artificial Intelligence (AI) staff member will do a predictive model to try and estimate the EF based on the PPG waveform.

Secondary outcomes

  1. Association between blood pressure and PPG waveforms

    Time frame: Day1

    The investigators will record the blood pressure of the patient twice during their visit. Then, the Artificial Intelligence (AI) staff member will do a predictive model to try and estimate the blood pressure based on the PPG waveform.

Study contacts

Contact information is provided by the study sponsor or research team.

Kunal Sameer, MD, MHA

CONTACT

[email protected]

504-988-3072

Mayana Bsoul, MD

CONTACT

[email protected]

504-988-3063

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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