VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Protocol for Validation Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- cardio-ankle vascular index (CAVI) validation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects ≥ 18 years who agree to participate in the study and do not meet any of the exclusion criteria.
排除标准
- •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
结局指标
主要结局
cardio-ankle vascular index (CAVI) validation
时间窗: 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.
次要结局
未报告次要终点
研究者
Sergio Rico Martín
PhD. RN. Associate Professor
University of Extremadura