Trial document





This trial has been registered retrospectively.
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  DRKS00013568

Trial Description

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Title

Development and validation of ultrasound elastography of the aorta for assessment of the central cardiovascular system

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Trial Acronym

USEAo

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URL of the Trial

http://elastography.de

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Brief Summary in Lay Language

Cardiovascular diseases are one of the most common causes of serious illness in the Western world. In this context, increasing vascular stiffness, which is aggravated by arterial hypertension, is an important factor in the pathogenesis and deterioration of cardiovasculars diseases. The increase in stiffness of large central arteries has serious consequences for the human body, since it i.a. reduces bloodflow in the coronary arteries and thus impairs cardiac output. The aim of this study is to further develop and validate ultrasound elastography regarding a quantification of the stiffness of the aorta in order to detect an end organ damage of the large arteries at an early stage.

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Brief Summary in Scientific Language

The aim of this study is the implementation and validation of ultrasound elastography (USE) of the aorta for the purpose of spatially resolved quantification of vascular stiffness. With USE, a possible end organ damage of the aorta may be quantified directly by means of mechanical characteristics.

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Organizational Data

  •   DRKS00013568
  •   2018/03/07
  •   [---]*
  •   yes
  •   Approved
  •   EA1/056/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I10-I15 -  Hypertensive diseases
  •   I70-I79 -  Diseases of arteries, arterioles and capillaries
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Interventions/Observational Groups

  •   Patients with diagnosed arterial hypertension. Patients undergo measurements of pulse wave velocity and peripheral blood pressure as well as ultrasound elastography of the aorta.
  •   Healthy volunteers. Volunteers undergo measurements of pulse wave velocity and peripheral blood pressure as well as ultrasound elastography of the aorta.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome is the successful measurement of regional aortic stiffness in healthy volunteers and patients with the help of ultrasound elastograpyh. This is a feasibility study with the purpose of introducing a new diagnostic parameter.

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Secondary Outcome

Derivation of diagnostic parameters. Comparison of derived parameters with established methods.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/01/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

History of arterial hypertension or healthy volunteers

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Exclusion Criteria

pregnancy, acute myocardial infarction or stroke within 14 days before the examination

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Addresses

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    • Klinik und Hochschulambulanz für Radiologie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin
    • Mr.  Priv.-Doz. Dr. med.  Thomas  Elgeti 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Institut für Radiologie, Campus Charité Mitte, Charité-Universitätsmedizin Berlin
    • Mr.  Prof. Dr. rer. nat.  Ingolf  Sack 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Klinik und Hochschulambulanz für Radiologie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin
    • Mr.  Priv.-Doz. Dr. med.  Thomas  Elgeti 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Klinik und Hochschulambulanz für Radiologie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin
    • Mr.  Dr. med.  Lars-Arne  Schaafs 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Benjamin Franklin
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.