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

NCT ID: NCT04303546

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-08

Study Completion Date

2020-12-15

Brief Summary

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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

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Conditions

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Cardiovascular Risk Factor Cardiovascular Diseases Atherosclerosis of Artery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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< 30 years

arterial stiffness measurements

Intervention Type DEVICE

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

30-60 years

arterial stiffness measurements

Intervention Type DEVICE

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

> 60 years

arterial stiffness measurements

Intervention Type DEVICE

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

Interventions

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arterial stiffness measurements

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Extremadura

OTHER

Sponsor Role lead

Responsible Party

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Sergio Rico Martín

PhD. RN. Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 33082193 (View on PubMed)

Other Identifiers

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VOPITB STUDY

Identifier Type: -

Identifier Source: org_study_id

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