Validation of Optical Device for Aortic Pulse Wave Velocity Measurement

Study Overview
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Brief Summary
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Existing techniques available for capturing reliable aortic pulse wave velocity measurements and estimating aortic stiffness are costly and require technical expertise. The purpose of this research is to investigate an oximeter device performance as a stand-alone aortic pulse wave velocity (PWV) measurement instrument. By validating this device and its measurements against the gold-standard method of carotid-femoral readings, we aim to demonstrate that the proposed method is an comparably effective in terms of the metrics (Mean difference, standard deviation, correlation, etc.) outlined by the Artery Society Guidelines.

Official Title
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Validation of Photoplethysmography Device for the Measurement of Aortic Pulse Wave Velocity Against Carotid-Femoral Values From Piezoelectric Sensors

Conditions
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Aortic Pulse Wave Velocity

Intervention / Treatment
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* Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: History of cardiovascular disease Not in sinus rhythm/arrhythmia Pacemaker Impalpable arterial pulse Use of blood pressure medication Systolic blood pressure > 140 Use of vasoactive medication Use of cholesterol medication Diabetes diagnosis Smokers BMI > 30 kg/m2 Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Device Calibration & Algorithm Training<br>The data obtained from this group will be used to a) quantify the relationship between PWV measured at the groin versus the thigh for less intrusive future piezo sensor placement and b) train the proposed device for the next cohort. | Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure<br>* Carotid-femoral aortic pulse wave velocity will be compared against values collected from the oximeter system. The former is assessed by placing piezoelectric pressure sensors at three locations: the right common carotid artery, the right common femoral artery (groin), and the right superficial femoral artery (thigh). The oximeter will be secured on the right index finger. Simultaneous data collection will occur for both methods, with each trail lasting 60 seconds.<br>|
| Device & Algorithm Testing<br>The gold-standard and new device values will be collected from this group to validate the previously trained system. | Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure<br>* Carotid-femoral aortic pulse wave velocity will be compared against values collected from the oximeter system. The former is assessed by placing piezoelectric pressure sensors at three locations: the right common carotid artery, the right common femoral artery (groin), and the right superficial femoral artery (thigh). The oximeter will be secured on the right index finger. Simultaneous data collection will occur for both methods, with each trail lasting 60 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic Pulse Wave Velocity | The speed at which a single pulse/heart beat propagates down the aorta. | 6 measurements per subject, each lasting 60 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic pulse wave velocity, plethysmography