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

NCT04303546 | Unknown

• 1 other identifier: VOPITB STUDY
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Risk Factor; Cardiovascular Diseases; Atherosclerosis of Artery

Keywords

arterial stiffnes; pulse wave velocity; VOPITB; validation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

< 30 years

Device: arterial stiffness measurements

30-60 years

Device: arterial stiffness measurements

> 60 years

Device: arterial stiffness measurements

Interventions

arterial stiffness measurements DEVICE

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

30-60 years; < 30 years; > 60 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Extremadura: lead

Related Publications (1)

• Rico Martin S, Vassilenko V, de Nicolas Jimenez JM, Rey Sanchez P, Serrano A, Martinez Alvarez M, Calderon Garcia JF, Sanchez Munoz-Torrero JF. Cardio-ankle vascular index (CAVI) measured by a new device: protocol for a validation study. BMJ Open. 2020 Oct 20;10(10):e038581. doi: 10.1136/bmjopen-2020-038581.

  PMID: 33082193 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. RN. Associate Professor

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 11, 2020
• Study Start: March 8, 2020
• Primary Completion: April 15, 2020
• Study Completion: December 15, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share