Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 主要终点
- central arterial stiffness
研究概览
简要总结
The significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level. The purpose of this study is to evaluate the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland).
详细描述
The proposed study is an open, monocentric cross-sectional research study for the evaluation of the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland). For that purpose measurement of the respective parameters in cardiovascular disease free individuals will be compared with validated devices and the agreement between the devices will be statistically analyzed. Central blood pressure and central arterial stiffness are clinically increasingly meaningful parameters of the cardiovascular system that allow improved, early cardiovascular risk stratification. The significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Healthy individuals free of clinically relevant cardiovascular diseases or diabetes based on medical history and physical examination.
- •Heart rhythm: Sinus rhythm
- •Blood pressure range: 10 to 12 subjects in each of the three systolic blood pressure (SBP) and three diastolic blood pressure (DBP) recruitment ranges (low, medium, high).
排除标准
- •Cardiac arrhythmia (atrial fibrillation, frequent extrasystoles)
- •Pacemaker-dependent
- •Pregnancy after the 6th month of the pregnancy
- •Body mass index (BMI)>30 kg/m2
- •Known significant carotid or femoral artery stenosis
- •Impalpable arterial pulse at site of measurement
- •Age under 18 years.
结局指标
主要结局
central arterial stiffness
时间窗: 1 day
Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device
central blood pressure
时间窗: 1 day
Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device
次要结局
- peripheral blood pressure(1 day)
研究者
Arno Schmidt-Trucksäss
Professor Dr. Arno Schmidt-Trucksäss
University of Basel