Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband

NCT05279066 | Unknown

• 1 other identifier: 21-001030
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will compare the accuracy of the Biostrap wristband, a wearable device with a clinical-grade Photoplethysmography (PPG) sensor, to measure ejection fraction and cardiac output in patients undergoing a cardiac ultrasound and pulmonary arterial catheterization, respectively.

Conditions

Heart Failure

Keywords

ejection fraction; cardiac output

Outcome Measures

Primary Outcomes (2)

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

  Patients scheduled to undergo a cardiac ultrasound will wear the Biostrap wristband for the duration of the echocardiogram (1-2 hours) and a PPG waveform will be obtained from the device. The ejection fraction (measured in units of %) will also be obtained 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. PPG-derived outcome measures will be derived from a two-step process of raw data collection followed by application of waveform derivative algorithms. They will perform an in-depth beat shape analysis of the PPG waveform that includes identifying dozens of features and critical points of each beat to derive the Ejection fraction (calculated in units of %).

  6 months

• Association between obtained PPG waveforms and recorded cardiac outputs (CO)

  Patients scheduled to undergo a pulmonary arterial catheterization in the cardiac ICU will wear the biostrap wristband for 7 days and a PPG waveform will be obtained from the device. The cardiac output values (measured in units of mL and recorded using the PA catheter) will also be obtained from the patient's medical record. Then, the Artificial Intelligence (AI) staff member will do a predictive model to try and estimate the CO based on the PPG waveform. PPG-derived outcome measures will be derived from a two-step process of raw data collection followed by application of waveform derivative algorithms. They will perform an in-depth beat shape analysis of the PPG waveform that includes identifying dozens of features and critical points of each beat to derive the Cardiac Output (calculated in unites of mL).

  6 months

Study Arms (2)

Patients scheduled to undergo an elective cardiac ultrasound

All cardiac patients undergoing an elective cardiac ultrasound as an outpatient at UCLA may be asked to participate in the study. The investigators will identify eligible patients from their medical record. If interested, patients will be consented prior to their scheduled ultrasound.

Device: Biostrap Wristband

Patients with a pulmonary arterial catheterization scheduled or completed

All patients hospitalized in the cardiac ICU at UCLA with a pulmonary arterial catheterization scheduled or completed may be asked to participate in the study. The investigators will identify eligible patients from their medical record. If interested, patients will be consented during their hospital stay.

Device: Biostrap Wristband

Interventions

Biostrap Wristband DEVICE

The Biostrap Wristband device is a non-invasive optical sensor that monitors changes in arterial pulse volume using Photoplethysmography (PPG). PPG is frequently used in wearable sensors to detect heart rate as well as other metrics such as heart rate variability (HRV) and respiratory rate. The raw biosignals recorded by the wristband device will be further processed to estimate the ejection fraction and cardiac output.

Patients scheduled to undergo an elective cardiac ultrasound; Patients with a pulmonary arterial catheterization scheduled or completed

Eligibility Criteria

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

Study Population

Men and woman over the age of 18 years old.

You may qualify if:

• ≥ 18 years of age.
• Subjects who are undergoing elective cardiac ultrasound as an outpatient for group 1 or are scheduled for/completed a pilmonary arterial catheterization for group 2.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

You may not qualify if:

• \. Subject is unable or unwilling to wear the wristband for the required duration.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Suzan Khalil

CONTACT

3102676957; skhalil@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: March 15, 2022
• Study Start: March 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

US (1)