Recruiting

Observational Study

Sponsor:

Tulane University

Code:

NCT04843371

Conditions

Valvular Heart Disease

Pericardial Disease

Cardiomyopathies

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Photoplethysmography

Study Details

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

Study ID

NCT04843371

Start date

Aug 20, 2021

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Association between obtained PPG waveforms and recorded ejection (EF) fractions. [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Mayana Bsoul, MD

504-988-3063mbsoul@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Locations

East Jefferson General Hospital

Recruiting

New Orleans, Louisiana, United States, 70006

Contacts

Mayana Bsoul, MD

504-988-3063mbsoul@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Nassir Marrouche, MD

University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Mayana Bsoul, MD

504-988-3063mbsoulmbsoul@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Nassir Marrouche, MD

Tulane Doctors - Speciality Care - Napoleon

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Mayana Bsoul, MD

504-988-3063mbsoul@tulane.edu

Kunal Sameer, MD, MHA

504-988-3072ksameer@tulane.edu

Principal Investigator:

Nassir Marrouche, MD

More Information

Sponsor

Tulane University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Structural heart disease
  • Photoplethysmography
  • Ejection Fraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-03-05.