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NCT04303546 Clinical Trial

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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04303546
Other study ID # VOPITB STUDY
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 8, 2020
Est. completion date December 15, 2020

Study information
Verified date March 2020
Source University of Extremadura
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date December 15, 2020
Est. primary completion date April 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• arterial stiffness measurements
We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Extremadura

Outcome
Type Measure Description Time frame Safety issue
Primary cardio-ankle vascular index (CAVI) validation 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
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