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

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ClinicalTrials.gov Identifier: NCT02596165
Recruitment Status : Terminated (Stopp because of FDA concrns regarding recruitment.)
First Posted : November 4, 2015
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Kantonsspital Liestal
Information provided by (Responsible Party):
Arno Schmidt-Trucksäss, University of Basel

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Aortic Stiffness Hypertension Device: Pulse wave analysis measurement with Schiller BR-102 Plus PWA device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
Actual Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. central blood pressure [ Time Frame: 1 day ]
    Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device

  2. central arterial stiffness [ Time Frame: 1 day ]
    Measurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device


Secondary Outcome Measures :
  1. peripheral blood pressure [ Time Frame: 1 day ]
    Measurement peripheral blood pressure with the Schiller BR-102 Plus PWA device



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596165


Sponsors and Collaborators
University of Basel
Kantonsspital Liestal
Investigators
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Principal Investigator: Arno Schmidt-Trucksäss, MD, MA Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel, Basel, Switzerland, 4052
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Responsible Party: Arno Schmidt-Trucksäss, Professor Dr. Arno Schmidt-Trucksäss, University of Basel
ClinicalTrials.gov Identifier: NCT02596165    
Other Study ID Numbers: EKNZ 2015-327
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Keywords provided by Arno Schmidt-Trucksäss, University of Basel:
validation
pulse wave analysis
blood pressure monitoring
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases