Trial document





This trial has been registered retrospectively.
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  DRKS00006161

Trial Description

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Title

Diagnosis and follow up of giant cell arteritis by high-frequency ultrasound

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006161
  •   2015/01/09
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  •   yes
  •   Approved
  •   A 152/12, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  •   CIV-12-11-009241 
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Health Condition or Problem studied

  •   M31.6 -  Other giant cell arteritis
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Interventions/Observational Groups

  •   Sonographic examination of patients with chronic diseases and drug treatment with high-frequency ultrasound as well as by standard ultrasound examination.
  •   Sonographic examination of patients with acute diseases and without therapy with high-frequency ultrasound as well as by standard ultrasound examination.
  •   Sonographic examination of a control group without giant cell arteritis with high-frequency ultrasound as well as by standard ultrasound examination.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Wall thickness of arteria temporalis.

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Secondary Outcome

Arterial wall calcification, pattern of arterial wall changes, pattern of involvement of the artery (continuous or segmental).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/05/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients of the Department of Ophthalmology and Section of Rheumatology of UKSH, Campus Kiel, are included if: a.) They have a suspicion of acute arteritis temporalis b.) They have already diagnosed arteritis temporalis and get a long-term immunsuppressive therapy with currently inactive stage of disease. Age ≥ 50 years. All patients must have signed a declaration to consent.
Control group:
Patients ≥ 50 years. Patients who been examined in the context of trauma surgery aftercare with radiological diagnosis in the Department of Diagnostic Radiology, Campus Kiel are included in the control group. All patients must have signed a declaration to consent.

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Exclusion Criteria

Patients who are < 50 years old or incapacitated be excluded. Patients with chronic inflammatory diseases, acute inflammatory disease and / or immunosuppressive drug therapy duration are excluded from the study. Patients who are unable to walk or can not be transported are also excluded.

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Addresses

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    • UKSH
    • 24105  Kiel
    • Germany
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    • UKSH, Klinik für Radiologie und Neuroradiologie, Kiel
    • Mr.  PD Dr.  Marcus  Both 
    • Arnold-Heller Str. 3
    • 24105  Kiel
    • Germany
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    • UKSH, Klinik für Radiologie und Neuroradiologie
    • Ms.  Dr. med.  Antonia  Bartels 
    • Arnold Heller Str. 3, Haus 41
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Radiologie und Neuroradiologie
    • Arnold-Heller-Straße 3
    • 24105  Kiel
    • 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.