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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 28, 2015
First Posted Date  ICMJE November 4, 2015
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
peripheral blood pressure [ Time Frame: 1 day ]
Measurement peripheral blood pressure with the Schiller BR-102 Plus PWA device
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
Official Title  ICMJE Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Aortic Stiffness
  • Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Device: Pulse wave analysis measurement with Schiller BR-102 Plus PWA device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 13, 2020)
45
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2015)
75
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02596165
Other Study ID Numbers  ICMJE EKNZ 2015-327
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arno Schmidt-Trucksäss, University of Basel
Study Sponsor  ICMJE University of Basel
Collaborators  ICMJE Kantonsspital Liestal
Investigators  ICMJE
Principal Investigator: Arno Schmidt-Trucksäss, MD, MA Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel, Basel, Switzerland, 4052
PRS Account University of Basel
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP