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

Tulane University

Status: Enrolling

Conditions: Valvular Heart Disease; Pericardial Disease; Cardiomyopathies

Treatments: Diagnostic Test: Photoplethysmography

Study type: Observational

Funder types: Other

Identifiers

NCT04843371

2021-441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Patient Group

Description:

All patients undergoing an echocardiogram at Tulane Medical Center may be asked to participate in the study. Doctors, including PI and co-PI, will identify eligible patients from their clinic using their clinical knowledge and expertise and the patients' medical history and records. They will provide patients with information regarding the study and if interested, patients will be consented prior to their scheduled echocardiogram.

Treatment:

Diagnostic Test: Photoplethysmography