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

Sponsor
Tulane University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04843371
Collaborator
(none)
100
1
23.4
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Photoplethysmography

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Photoplethysmography (PPG) to Predict Ejection Fraction and Other Echographic Data in the General Population
Actual Study Start Date :
Aug 20, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

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

  1. Association between blood pressure and PPG waveforms [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tulane University Medical Center New Orleans Louisiana United States 70112

Sponsors and Collaborators

  • Tulane University

Investigators

  • Principal Investigator: Nassir Marrouche, MD, Tulane University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tulane University
ClinicalTrials.gov Identifier:
NCT04843371
Other Study ID Numbers:
  • 2021-441
First Posted:
Apr 13, 2021
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tulane University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022