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

NCT ID: NCT02596165

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

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.

Conditions

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Aortic Stiffness Hypertension

Keywords

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validation pulse wave analysis blood pressure monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pulse wave analysis measurement

Measurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device

Group Type EXPERIMENTAL

Pulse wave analysis measurement with Schiller BR-102 Plus PWA device

Intervention Type DEVICE

Measurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device

Interventions

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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

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kantonsspital Liestal

OTHER

Sponsor Role collaborator

University of Basel

OTHER

Sponsor Role lead

Responsible Party

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Arno Schmidt-Trucksäss

Professor Dr. Arno Schmidt-Trucksäss

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arno Schmidt-Trucksäss, MD, MA

Role: PRINCIPAL_INVESTIGATOR

Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel, Basel, Switzerland, 4052

Other Identifiers

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EKNZ 2015-327

Identifier Type: -

Identifier Source: org_study_id