Heart FailureNCT05279066
Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband
An observational study of Heart Failure, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Biostrap Wristband
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and woman over the age of 18 years old.
Who may be able to join
- ≥ 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.
Who cannot join
- 1. Subject is unable or unwilling to wear the wristband for the required duration.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Suzan Khalil, MD, 310-267-6957, skhalil@mednet.ucla.edu
Ali Nsair, MD
About this study
Official title: A Clinical Validation Study for Measuring Cardiac Output and Ejection Fraction Using a Wrist-worn Device.
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.
Read the detailed description
This in an introductory clinical study with both cardiac patients undergoing elective cardiac ultrasound and cardiac ICU patients with pulmonary arterial catheters featuring Biostrap wristband. This is a single site, non-blinded, non-randomized study. The wristband is a wearable device that contains a clinical-grade Photoplethysmography (PPG) sensor which will measure parameters quasi-continuously and non-invasively. The device, Biostrap wristband, will measure cardiac ejection fraction (EF) and cardiac output (CO). We will enroll a total of 100 patients: 2 groups of 50. 50 patients undergoing an elective cardiac ultrasound as part of their routine medical care will wear the device for 1-2 hours as an outpatient depending on the duration of the test. 50 hospitalized patients with a scheduled or completed pulmonary arterial catheter inserted as part of their standard medical care will wear the device for 7 days.
The investigators will perform a retrospective analysis comparing the accuracy of EF and CO measured by the device in comparison to those from a 'reference device', which is the cardiac ultrasound for ejection fraction and the pulmonary arterial catheter for cardiac output values. Cardiac Ultrasound and pulmonary arterial catheters are standard of care procedures.
- Conditions
- Heart Failure
- Being tested
- Biostrap Wristband
- Keywords
- ejection fraction, cardiac output
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biostrap WristbandDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Biostrap Wristband |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %).
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start15 Mar 2022 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Nsair, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279066
- Sponsor's protocol ID
- 21-001030
- Status last verified
- Mar 2022
- First submitted
- 27 Jan 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Validation Study for Measuring Cardiac Output and Ejection Fraction Using a Wrist-worn Device.
- ClinicalTrials.gov ID
- NCT05279066
- Acronym / sponsor ID
- 21-001030
- Conditions
- Heart Failure
- Keywords
- ejection fraction, cardiac output
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This in an introductory clinical study with both cardiac patients undergoing elective cardiac ultrasound and cardiac ICU patients with pulmonary arterial catheters featuring Biostrap wristband. This is a single site, non-blinded, non-randomized study. The wristband is a wearable device that contains a clinical-grade Photoplethysmography (PPG) sensor which will measure parameters quasi-continuously and non-invasively. The device, Biostrap wristband, will measure cardiac ejection fraction (EF) and cardiac output (CO). We will enroll a total of 100 patients: 2 groups of 50. 50 patients undergoing an elective cardiac ultrasound as part of their routine medical care will wear the device for 1-2 hours as an outpatient depending on the duration of the test. 50 hospitalized patients with a scheduled or completed pulmonary arterial catheter inserted as part of their standard medical care will wear the device for 7 days.
The investigators will perform a retrospective analysis comparing the accuracy of EF and CO measured by the device in comparison to those from a 'reference device', which is the cardiac ultrasound for ejection fraction and the pulmonary arterial catheter for cardiac output values. Cardiac Ultrasound and pulmonary arterial catheters are standard of care procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled to undergo an elective cardiac ultrasound | – | Device: Biostrap WristbandAll 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. |
| Patients with a pulmonary arterial catheterization scheduled or completed | – | Device: Biostrap WristbandAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and woman over the age of 18 years old.
Key inclusion criteria (3 listed)
- ≥ 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.
Key exclusion criteria (1 listed)
- 1. Subject is unable or unwilling to wear the wristband for the required duration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biostrap WristbandThe 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. | Device | Patients scheduled to undergo an elective cardiac ultrasound, Patients with a pulmonary arterial catheterization scheduled or completed |
Primary outcome
Association between obtained PPG waveforms and recorded ejection (EF) fractions
Time frame: 6 months
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 %).
Association between obtained PPG waveforms and recorded cardiac outputs (CO)
Time frame: 6 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzan Khalil (3102676957, skhalil@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between obtained PPG waveforms and recorded ejection (EF) fractions (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.