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

University of Extremadura

Status: Unknown

Conditions: Cardiovascular Diseases; Cardiovascular Risk Factor; Atherosclerosis of Artery

Treatments: Device: arterial stiffness measurements

Study type: Observational

Funder types: Other

Identifiers

NCT04303546

VOPITB STUDY

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

< 30 years

Treatment:

Device: arterial stiffness measurements

30-60 years

Treatment:

Device: arterial stiffness measurements

> 60 years

Treatment:

Device: arterial stiffness measurements