Validation of Optical Device for Aortic Pulse Wave Velocity Measurement

June 1, 2022 updated by: VitalSines International Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic patients with a health cardiovascular background.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Device Calibration & Algorithm Training
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
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.
Device & Algorithm Testing
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 measurements per subject, each lasting 60 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VitalSines International Inc.

Investigators

  • Principal Investigator: Jess Goodman, M.D., VitalSines International Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OBA-MAPWV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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