Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 10:26 AM
Study NCT ID:
NCT05279066
Status:
UNKNOWN
Last Update Posted:
2022-03-15
First Post:
2022-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2022-01-27', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between obtained PPG waveforms and recorded ejection (EF) fractions', 'timeFrame': '6 months', 'description': '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 %).'}, {'measure': 'Association between obtained PPG waveforms and recorded cardiac outputs (CO)', 'timeFrame': '6 months', 'description': "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)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ejection fraction', 'cardiac output'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and woman over the age of 18 years old.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years of age.\n2. 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.\n3. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1\\. Subject is unable or unwilling to wear the wristband for the required duration.'}, 'identificationModule': {'nctId': 'NCT05279066', 'briefTitle': 'Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'A Clinical Validation Study for Measuring Cardiac Output and Ejection Fraction Using a Wrist-worn Device.', 'orgStudyIdInfo': {'id': '21-001030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients scheduled to undergo an elective cardiac ultrasound', 'description': '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.', 'interventionNames': ['Device: Biostrap Wristband']}, {'label': 'Patients with a pulmonary arterial catheterization scheduled or completed', 'description': '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.', 'interventionNames': ['Device: Biostrap Wristband']}], 'interventions': [{'name': 'Biostrap Wristband', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Patients scheduled to undergo an elective cardiac ultrasound', 'Patients with a pulmonary arterial catheterization scheduled or completed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Suzan Khalil, MD', 'role': 'CONTACT', 'email': 'skhalil@mednet.ucla.edu', 'phone': '310-267-6957'}, {'name': 'Ali Nsair, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Suzan Khalil', 'role': 'CONTACT', 'email': 'skhalil@mednet.ucla.edu', 'phone': '3102676957'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Ali Nsair, MD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}