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

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).

Study Overview

• Status: Terminated
• Conditions: Hypertension; Aortic Stiffness
• Intervention / Treatment: Device: Pulse wave analysis measurement with Schiller BR-102 Plus PWA device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Basel
• Collaborators: Kantonsspital Liestal
• Investigators: Principal Investigator: Arno Schmidt-Trucksäss, MD, MA, Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel, Basel, Switzerland, 4052

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: validation; pulse wave analysis; blood pressure monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: EKNZ 2015-327