VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Validation Study

March 10, 2020 updated by: Sergio Rico Martín, University of Extremadura

VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Protocol for Validation Study

Our group has developed a device called "Velocidad Onda de Pulso Indice Tobillo Brazo (VOPITB)" . In this device the oscillometric method is used for easily and accurately measure the pulse wave velocity PWV in the arms and legs separately, allowing new arterial stiffness indices to be studied (sum, difference, ratio, baPWV and CAVI). The aim of our study will be to validate the PWV measures by VOPITB with other references devices that measures arterial stiffness. Moreover we will perform a clinical study to assess the clinical utility of VOPITB.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The sample size has been calculated in order to provide that a difference between the CAVI values obtained from measurement of both devices, VOPITB and VaSera, shall be up to of 0.8 points in comparison with the CAVI reference values for Spanish adults population [21]. the base parameters used to calculate the sample size were as follows: standard deviation (sd) of CAVI measured by VaSera VS-1500 and VOPITB (1.44), mean difference between CAVI measurements (0.8), confidence level (95%), and power (80%). Thus, the estimated sample size was found as 102 patients. In addition, for compensating possible incomplete data sets from patients who could withdraw or fail to complete the study, 20% were added. Finally, a total of 120 subjects (a minimum of 40% of subjects for each gender group) will be evaluated according to the following criteria:

  • < 30 years (40 subjects)
  • 30 - 60 years (40 subjects)
  • > 60 years (40 subjects)

Description

Inclusion Criteria:

  • Subjects ≥ 18 years who agree to participate in the study and do not meet any of the exclusion criteria.

Exclusion Criteria:

  • History of CVD (ischaemic heart disease, stroke or peripheral arterial disease)
  • Atrial fibrillation or other cardiac rhythm disorders
  • Pacemaker-dependent
  • Impalpable arterial pulse at site of measurement
  • Pregnancy
  • Terminal condition
  • Age under 18 years

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
< 30 years
Device: arterial stiffness measurements
We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB
30-60 years
Device: arterial stiffness measurements
We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB
> 60 years
Device: arterial stiffness measurements
We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardio-ankle vascular index (CAVI) validation
Time Frame: 8 months
We will determine CAVI with VOPITB, as well as its validation against the reference device (VaSera VS-1500) and assess its clinical utility.
8 months

Collaborators and Investigators

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

Sponsor

University of Extremadura

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)

March 8, 2020

Primary Completion (Anticipated)

April 15, 2020

Study Completion (Anticipated)

December 15, 2020

Study Registration Dates

First Submitted

March 8, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOPITB STUDY

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

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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