Trial document




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  DRKS00009324

Trial Description

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Title

Influence Of Circulating Microvesicles On Vascular Inflammation

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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

Circulating microvesicles are a means of intercellular and inter-organ-communication even across large distances (e.g. heart-brain). In this study we want to investigate the characteristics of secreted microvesicles of circulating leukocytes in patients with atherosclerosis compared to healthy subjects.

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Organizational Data

  •   DRKS00009324
  •   2015/09/07
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  •   yes
  •   Approved
  •   EA2/059/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   I25.1 -  Atherosclerotic heart disease
  •   I70.2 -  Atherosclerosis of arteries of extremities
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Interventions/Observational Groups

  •   Healthy volunteers: one-time blood draw, rewiev of medical history
  •   Patients with coronary artery disease: one-time blood draw, rewiev of medical history
  •   Patients with peripheral artery occlusive disease: one-time blood draw, rewiev of medical history
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Blinded
  •   assessor
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Microvesicle secretion profiles of different circulating leukocytes in healthy subjects and patients with coronary artery disease or peripheral artery occlusive disease

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Secondary Outcome

Microvesicle function in different leukocyte populations in healthy subjects and patients with coronary artery disease or peripheral artery occlusive disease

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/01/26
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   75   Years
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Additional Inclusion Criteria

1. in all groups age between 30 and 75 years
2. in all groups male and female subjects
Age and sex should be homogenously distributed among study arms
Group 1: healthy volunteers (i.e. no known cardiac disease, no family history)
Group 2: patients with stable coronary artery disease
Groups 3: patients with peripheral artery occlusive disease

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Exclusion Criteria

1. pregnancy
2. renal failure (creatinin >265 umol)
3. liver failure
4. disease of the hematopoetic system
5. malignancy within the past 5 years (without evidence of relapse at time of inclusion)
6. acute or chronic inflammation
7. acute vascular event (e.g. myocardial infarction, stroke, pulmonary or systemic embolism) within the last year
8. inability to give informed consent
9. solid organ transplantation in history
10. acute shock
11. metabolic diseases including heredetary lipometabolic diseases and diabetes

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Universitätsmedizin BerlinKlinik für KardiologieCampus Benjamin Franklin
    • Mr.  Prof. Dr.  Ulf  Landmesser 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité Universitätsmedizin BerlinKlinik für KardiologieCampus Benjamin Franklin
    • Ms.  Dr.  Nicolle  Kränkel 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charité Universitätsmedizin BerlinKlinik für KardiologieCampus Benjamin Franklin
    • Ms.  Dr.  Julia-Christine  Jordan 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • DZHK - Deutsches Zentrum für Herz-Kreislauf-Forschung e.V.
    • Oudenarder Str. 16
    • 13347  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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