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

• Conditions: Atherosclerosis of Artery; Cardiovascular Risk Factor; Cardiovascular Diseases
• Interventions: Device: arterial stiffness measurements

• Registration Number: NCT04303546
• Lead Sponsor: University of Extremadura

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-08
• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-11
• Last Update Posted: 2020-03-11
• Primary Completion: 2020-04-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
< 30 years	arterial stiffness measurements	-
30-60 years	arterial stiffness measurements	-
> 60 years	arterial stiffness measurements	-

Primary Outcome Measures

Name	Time	Method
cardio-ankle vascular index (CAVI) validation	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.