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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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 satu

Первичные конечные точки

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

Вторичные конечные точки (1)

• Association between blood pressure and PPG waveforms [Срок оценки: Day1]

Критерии участия

Критерии включения

• Male or Female aged18 years or older.
• Patients scheduled to undergo an echocardiogram at Tulane Medical Center.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 3 центра

• East Jefferson General Hospital — New Orleans
• University Medical Center — New Orleans
• Tulane Doctors - Speciality Care - Napoleon — New Orleans

Публикации

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• Redfield MM, Rodeheffer RJ, Jacobsen SJ, Mahoney DW, Bailey KR, Burnett JC Jr. Plasma brain natriuretic peptide to detect preclinical ventricular systolic or diastolic dysfunction: a community-based study. Circulation. 2004 Jun 29;109(25):3176-81. doi: 10.1161/01.CIR.0000130845.38133.8F. Epub 2004 Jun 7. PMID 15184280
• Blanie A, Soued M, Benhamou D, Mazoit JX, Duranteau J. A Comparison of Photoplethysmography Versus Esophageal Doppler for the Assessment of Cardiac Index During Major Noncardiac Surgery. Anesth Analg. 2016 Feb;122(2):430-6. doi: 10.1213/ANE.0000000000001113. PMID 26649910
• Chan GS, Middleton PM, Celler BG, Wang L, Lovell NH. Automatic detection of left ventricular ejection time from a finger photoplethysmographic pulse oximetry waveform: comparison with Doppler aortic measurement. Physiol Meas. 2007 Apr;28(4):439-52. doi: 10.1088/0967-3334/28/4/009. Epub 2007 Mar 20. PMID 17395998
• Middleton PM, Chan GS, O'Lone E, Steel E, Carroll R, Celler BG, Lovell NH. Changes in left ventricular ejection time and pulse transit time derived from finger photoplethysmogram and electrocardiogram during moderate haemorrhage. Clin Physiol Funct Imaging. 2009 May;29(3):163-9. doi: 10.1111/j.1475-097X.2008.00843.x. Epub 2009 Jan 22. PMID 19170720

Идентификаторы

NCT: NCT04843371 · 2021-441

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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