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Clinical Trials/NCT05400421
NCT05400421
Unknown
Not Applicable

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

VitalSines International Inc.0 sites180 target enrollmentJune 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Pulse Wave Velocity
Sponsor
VitalSines International Inc.
Enrollment
180
Primary Endpoint
Aortic Pulse Wave Velocity
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2022
End Date
July 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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
  • BMI \> 30 kg/m2

Outcomes

Primary Outcomes

Aortic Pulse Wave Velocity

Time Frame: 6 measurements per subject, each lasting 60 seconds

The speed at which a single pulse/heart beat propagates down the aorta.

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