Clinical trial NCT04843371: PPG to Predict Ejection Fraction and Other Echographic Data in the General Population
Official title: Photoplethysmography (PPG) to Predict Ejection Fraction and Other Echographic Data in the General Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valvular Heart Disease
Pericardial Disease
Cardiomyopathies
Keywords: Structural heart disease
Photoplethysmography
Ejection Fraction
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing an echocardiogram at Tulane Medical Center may be asked to participate in the study.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Association between obtained PPG waveforms and recorded ejection (EF) fractions.
timeFrame: Day 1
Secondary outcomes:
measure: Association between blood pressure and PPG waveforms
timeFrame: Day1
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
Study officials:
affiliation: Tulane University
name: Nassir Marrouche, MD
role: PRINCIPAL_INVESTIGATOR
References:
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