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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006161 |
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Date of registration:
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09/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Diagnosis and follow up of giant cell arteritis by high-frequency ultrasound
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Scientific title:
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Diagnosis and follow up of giant cell arteritis by high-frequency ultrasound |
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Date of first enrolment:
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01/05/2014 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00006161 |
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Study type:
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interventional |
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Study design:
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Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: other; Study design purpose: diagnostic
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Marcus
Both |
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Address:
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Arnold-Heller Str. 3
24105
Kiel
Germany |
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Telephone:
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0431-597-0 |
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Email:
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mboth@rad.uni-kiel.de |
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Affiliation:
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UKSH, Klinik für Radiologie und Neuroradiologie, Kiel |
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Name:
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Antonia
Bartels |
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Address:
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Arnold Heller Str. 3, Haus 41
24105
Kiel
Germany |
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Telephone:
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0431-597-0 |
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Email:
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a.bartels@rad.uni-kiel.de |
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Affiliation:
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UKSH, Klinik für Radiologie und Neuroradiologie |
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
50 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Other giant cell arteritis
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M31.6
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M31.6
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Intervention(s)
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Group 1: Sonographic examination of patients with chronic diseases and drug treatment with high-frequency ultrasound as well as by standard ultrasound examination.
Group 2: Sonographic examination of patients with acute diseases and without therapy with high-frequency ultrasound as well as by standard ultrasound examination.
Group 3: 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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Primary Outcome(s)
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Wall thickness of arteria temporalis.
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Secondary Outcome(s)
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Arterial wall calcification, pattern of arterial wall changes, pattern of involvement of the artery (continuous or segmental).
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Secondary ID(s)
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CIV-12-11-009241
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Source(s) of Monetary Support
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Klinik für Radiologie und Neuroradiologie
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Ethics review
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Status: Approved
Approval date: 24/03/2014
Contact:
ethikkomm@email.uni-kiel.de
Ethik-Kommission der Medizinischen Fakultät der Christian-Albrechts-Universität zu Kiel
+49-431-50014191
ethikkomm@email.uni-kiel.de
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