Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics

Conditions
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Aortic Stiffness, Hypertension

Intervention / Treatment
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* Device: Pulse wave analysis measurement with Schiller BR-102 Plus PWA device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulse wave analysis measurement<br>Measurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device | Device: Pulse wave analysis measurement with Schiller BR-102 Plus PWA device<br>* Measurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central blood pressure | Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device | 1 day | 
| central arterial stiffness | Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peripheral blood pressure | Measurement peripheral blood pressure with the Schiller BR-102 Plus PWA device | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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validation, pulse wave analysis, blood pressure monitoring