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

NCT04843371 | Recruiting

• 1 other identifier: 2021-441
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Valvular Heart Disease; Pericardial Disease; Cardiomyopathies

Keywords

Structural heart disease; Photoplethysmography; Ejection Fraction

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 1

Secondary Outcomes (1)

• Association between blood pressure and PPG waveforms

  Day1

Study Arms (1)

Patient Group

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.

Diagnostic Test: Photoplethysmography

Interventions

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.

Patient Group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing an echocardiogram at Tulane Medical Center may be asked to participate in the study.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University: lead

Study Sites (3)

East Jefferson General Hospital

New Orleans, Louisiana, 70006, United States

RECRUITING

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

Tulane Doctors - Speciality Care - Napoleon

New Orleans, Louisiana, 70115, United States

RECRUITING

Related Publications (9)

• McDonagh TA, McDonald K, Maisel AS. Screening for asymptomatic left ventricular dysfunction using B-type natriuretic Peptide. Congest Heart Fail. 2008 Jul-Aug;14(4 Suppl 1):5-8. doi: 10.1111/j.1751-7133.2008.tb00002.x.

  PMID: 18772638 BACKGROUND

• Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet. 2001 May 5;357(9266):1385-90. doi: 10.1016/s0140-6736(00)04560-8.

  PMID: 11356434 BACKGROUND

• Priori SG, Blomstrom-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J, Elliott PM, Fitzsimons D, Hatala R, Hindricks G, Kirchhof P, Kjeldsen K, Kuck KH, Hernandez-Madrid A, Nikolaou N, Norekval TM, Spaulding C, Van Veldhuisen DJ; ESC Scientific Document Group. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015 Nov 1;36(41):2793-2867. doi: 10.1093/eurheartj/ehv316. Epub 2015 Aug 29. No abstract available.

  PMID: 26320108 BACKGROUND

• Betti I, Castelli G, Barchielli A, Beligni C, Boscherini V, De Luca L, Messeri G, Gheorghiade M, Maisel A, Zuppiroli A. The role of N-terminal PRO-brain natriuretic peptide and echocardiography for screening asymptomatic left ventricular dysfunction in a population at high risk for heart failure. The PROBE-HF study. J Card Fail. 2009 Jun;15(5):377-84. doi: 10.1016/j.cardfail.2008.12.002. Epub 2009 Jan 21.

  PMID: 19477397 BACKGROUND

• Redfield MM, Rodeheffer RJ, Jacobsen SJ, Mahoney DW, Bailey KR, Burnett JC Jr. Plasma brain natriuretic peptide to detect preclinical ventricular systolic or diastolic dysfunction: a community-based study. Circulation. 2004 Jun 29;109(25):3176-81. doi: 10.1161/01.CIR.0000130845.38133.8F. Epub 2004 Jun 7.

  PMID: 15184280 BACKGROUND

• Blanie A, Soued M, Benhamou D, Mazoit JX, Duranteau J. A Comparison of Photoplethysmography Versus Esophageal Doppler for the Assessment of Cardiac Index During Major Noncardiac Surgery. Anesth Analg. 2016 Feb;122(2):430-6. doi: 10.1213/ANE.0000000000001113.

  PMID: 26649910 BACKGROUND

• Chan GS, Middleton PM, Celler BG, Wang L, Lovell NH. Automatic detection of left ventricular ejection time from a finger photoplethysmographic pulse oximetry waveform: comparison with Doppler aortic measurement. Physiol Meas. 2007 Apr;28(4):439-52. doi: 10.1088/0967-3334/28/4/009. Epub 2007 Mar 20.

  PMID: 17395998 BACKGROUND

• Middleton PM, Chan GS, O'Lone E, Steel E, Carroll R, Celler BG, Lovell NH. Changes in left ventricular ejection time and pulse transit time derived from finger photoplethysmogram and electrocardiogram during moderate haemorrhage. Clin Physiol Funct Imaging. 2009 May;29(3):163-9. doi: 10.1111/j.1475-097X.2008.00843.x. Epub 2009 Jan 22.

  PMID: 19170720 BACKGROUND

• Nachman D, Gepner Y, Goldstein N, Kabakov E, Ishay AB, Littman R, Azmon Y, Jaffe E, Eisenkraft A. Comparing blood pressure measurements between a photoplethysmography-based and a standard cuff-based manometry device. Sci Rep. 2020 Sep 30;10(1):16116. doi: 10.1038/s41598-020-73172-3.

  PMID: 32999400 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases; Cardiomyopathies

Interventions

Photoplethysmography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Plethysmography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nassir Marrouche, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayana Bsoul, MD

CONTACT

504-988-3063; mbsoul@tulane.edu

Kunal Sameer, MD, MHA

CONTACT

504-988-3072; ksameer@tulane.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: August 20, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (3)