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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04303546
Enrollment
120
Registered
2020-03-11
Start date
2020-03-08
Completion date
2020-12-15
Last updated
2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis of Artery, Cardiovascular Diseases, Cardiovascular Risk Factor

Keywords

arterial stiffnes, pulse wave velocity, VOPITB, validation

Brief 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.

Interventions

DEVICEarterial stiffness measurements

We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB

Sponsors

University of Extremadura
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Subjects ≥ 18 years who agree to participate in the study and do not meet any of the

Exclusion criteria

.

Design outcomes

Primary

MeasureTime frameDescription
cardio-ankle vascular index (CAVI) validation8 monthsWe will determine CAVI with VOPITB, as well as its validation against the reference device (VaSera VS-1500) and assess its clinical utility.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026