Validation of Optical Device for Aortic Pulse Wave Velocity Measurement

• Conditions: Aortic Pulse Wave Velocity
• Interventions: Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure

• Registration Number: NCT05400421
• Lead Sponsor: VitalSines International Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Posted: 2022-06-01
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-06
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device & Algorithm Testing	System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure	The gold-standard and new device values will be collected from this group to validate the previously trained system.
Device Calibration & Algorithm Training	System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure	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.

Primary Outcome Measures

Name	Time	Method
Aortic Pulse Wave Velocity	6 measurements per subject, each lasting 60 seconds	The speed at which a single pulse/heart beat propagates down the aorta.