Clinical trial NCT05400421: Validation of Optical Device for Aortic Pulse Wave Velocity Measurement
Official title: Validation of Photoplethysmography Device for the Measurement of Aortic Pulse Wave Velocity Against Carotid-Femoral Values From Piezoelectric Sensors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Pulse Wave Velocity
Keywords: aortic pulse wave velocity
plethysmography
Lead sponsor: VitalSines International Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic patients with a health cardiovascular background.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Aortic Pulse Wave Velocity
timeFrame: 6 measurements per subject, each lasting 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VitalSines International Inc.
name: Jess Goodman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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