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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| < 30 years |
| ||
| 30-60 years |
| ||
| > 60 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arterial stiffness measurements | Device | We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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:
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33082193 | Derived | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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