Trial document




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  DRKS00005139

Trial Description

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Title

Analysis of endothelial function of patients with large vessel vasculitis and ANCA-associated small vessel vasculitis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients suffering from vasculitis (Wegener's granulomatosis, polyarteriitis nodosa, microskopic polyangiitis, Giant cell arteriitis and polymyalgia rheumatica) show an increased risk for kardiovascular events (such as myocardial infarction and stroke), which can not be explained alone by classic risk factors like hypertension, dyslipidemia, smoking, diabetes mellitus, etc. The vascular dysfunction, as the main step in the development of arteriosclerosis, is in rheumatic diseases probably influenced by chronic inflammation, in case of primary vasculitis caused by an immune reaction at the vascular wall.
The conventional estimation of cardiovascular risk by scoring-systems (10 year risk) reflects therefor in these patients not the actual risk, wich causes major difficulties in staging and treatment. The intention of this study is, to research procedures and serological markers to quantify the endothelial function of patients with primary vasculitis. Patients suffering from special forms of vasculitis will be examined using three different measurement methods: A dynamic retinal vessel analysis, an ultrasound examination of the cervical arteries and a measurement of endothelial function and blood circulation at the fingers of the patient. The results will be compared among themselves and with the general population and furthermore be correlated with the disease activity and the concentration of inflammatory markers in the patients blood. In addition potential marker proteins shall be identified in the patients blood by comparing their concentration to the disease activity and the measurement of vascular function. In the long term we hope to make a contribution to a more precise assessment of kardiovascular risk of these patients, which would allow a more adapted and better treatment.

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Brief Summary in Scientific Language

Patients suffering from primary vasculitis (Wegener's granulomatosis, polyarteriitis nodosa, microskopic polyangiitis, Giant cell arteriitis and polymyalgia rheumatica) show an increased risk for kardiovascular events (such as myocardial infarction and stroke), wich can not be explained alone by classic risk factors like hypertension, dyslipidemia, smoking, diabetes mellitus, etc. The endothelial dysfunction, as the main step in the development of arteriosclerosis, is in rheumatic diseases probably influenced by chronic inflammation, in case of primary vasculitis caused by an immune reaction at the vascular wall.
The conventional estimation of cardiovascular risk by scoring-systems (10 year risk) reflects therefor in these patients not the actual risk, wich causes major difficulties in staging and treatment. The intention of this study is, to research procedures and serological markers to quantify the endothelial function of patients with primary vasculitis. Patients with giant cell vasculitis, wegener's ganulomatosis, microskopic polyangiitis or churg-strauss-syndrom will be examined using four different measurement methods: A dynamic retinal vessel analysis with the dynamic vessel analyzer (DVA), the measurement of intima-media thickness of the A. carotis communis by ultrasound, an EndoPAT-measurement and an analysis of the circulation by laserdoppler at the fingers of the patient. The results will be compared among themselves and with the general population and furthermore be correlated with the disease activity and the concentration of inflammatory markers in the patients blood. In addition potential marker proteins should be identified in the patients blood by comparing their concentration to the disease activity and the measurement of vascular function. In the long term we hope to make a contribution to a more precise assessment of kardiovascular risk of these patients, wich would allow a more adapted and better treatment.

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Organizational Data

  •   DRKS00005139
  •   2013/07/29
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  •   yes
  •   Approved
  •   3820-07/13, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   M31.5 -  Giant cell arteritis with polymyalgia rheumatica
  •   M31.6 -  Other giant cell arteritis
  •   M31.3 -  Wegener granulomatosis
  •   M31.7 -  Microscopic polyangiitis
  •   M30.1 -  Polyarteritis with lung involvement [Churg-Strauss]
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Interventions/Observational Groups

  •   large vessel vasculitis (giant cell vasculitis) or ANCA-associated small vessel vasculitis (Wegener's granulomatosis, Churg-Strauss-syndrom, microskopic polyangiitis):

    1) dynamic retinal vessel analysis using the dynamic vessel analyzer (DVA)

    2) Ultrasound-measurement of Intima-media-thickness (IMT) of the A. carotis communis

    3) EndoPat-measurement

    4) laser-doppler-analysis of the circulation at the patients finger

    5) disease activity and course of disease: Birmingham vasculitits activity score (BVAS V3), vascular damage index (VDI), duration of disease, number/duration/severity of acute attacks;

    6) serological inflammation markers;

    7) p-/c-ANCAs, PR3, MPO (ELISA); S-Kreatinin, eGFR nach CKD-Epi, Proteinuria, blood picture, HbA1c, blood-lipids, ASAT, ALAT, GGT;

    8) serum-concentration of biomarkers: E-Selectin, epidermal growth factor, epidermal growth factor-like domain containing protein 7 and basic-fibroblast growth factor;

    9) serum-concentration of circulating endothel cells;

    10) serum-concentration of thombocytic microparticles
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1) RVA-measurement at the right eye using flickerlight after application of Tropicamid 1%: Baseline-measurement of the retinal vessels diameters for 50 seconds and measurement for 80 seconds after application of 20 seconds flickerlight. Performance of 3 of this measurement-circles.
2) EndoPAT-measurement: 5 minutes baseline-measurement and 5 minutes measurement after occlusion of the A. brachialis for a duration of 5 minutes.
3) laser-doppler-measurement: 5 minutes baseline-measurement and 5 minutes measurement after occlusion of the A. brachialis for a duration of 5 minutes.
4) ultrasound-measurement of the intima-media-thickness of the far wall of the A. carotis communis.

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Secondary Outcome

1) disease activity and course of disease: Birmingham vasculitits activity score (BVAS V3), vascular damage index (VDI), duration of disease, number/duration/severity of acute attacks; 2) serological inflammation markers; p-/c-ANCAs, PR3, MPO (ELISA); S-Kreatinin, eGFR nach CKD-Epi, Proteinuria, blood picture, HbA1c, blood-lipids, ASAT, ALAT, GGT; 3) serum-concentration of biomarkers: E-Selectin, epidermal growth factor, epidermal growth factor-like domain containing protein 7 and basic-fibroblast growth factor; 4) serum-concentration of circulating endothel cells; 5) serum-concentration of thombocytic microparticles

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2013/08/05
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients of the department of rheumatology. Age > 18 years. Presentation of large vessel vasculitis (giant cell vasculitis) or ANCA-associated small vessel vasulitis (Wegener's granulomatosis, Churg-Strauss-syndrom, microskopic polyangiitis) independend of disease activity. Existence of a consent form.

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Exclusion Criteria

Patients with another chronic-rheumatic disease or another systemic autoimmune disease. glaucoma or increased intraocular preasure. Coronary heart disease, peripherial artery disease, cerebrovascular disease, nephropathy with renal failure 4-5, diabetes mellitus, instable epilepsy, pregnancy/lactation.

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Addresses

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • Universitätsklinikum Jena Klinik für Innere Medizin 3 Rheumatologie
    • Mr.  Dr.  Thomas  Neumann 
    • Erlanger Allee 101
    • 07749  Jena
    • Germany
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    • Universitätsklinikum Jena Klinik für Innere Medizin 3 Rheumatologie
    • Mr.  Dr.  Thomas  Neumann 
    • Erlanger Allee 101
    • 07749  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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