Trial document




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  DRKS00009322

Trial Description

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Title

Influence of Lipoproteins From Patients With Coronary Artery Disease on The Differentiation of Hematopoetic Progenitor Cells

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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

Researchers agree that the pathophysiology of atherosclerosis consists at least of dyslipidemia and inflammation. Still, there is not much known about the interplay of both factors. In this study we seek to define new connections between pathologically altered blood lipoproteins and the immune system.

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Organizational Data

  •   DRKS00009322
  •   2015/09/04
  •   [---]*
  •   yes
  •   Approved
  •   EA4/122/14, 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
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   healthy volunteers: one-time blood draw, rewiev of medical history
  •   patients with coronary artery disease without diabetes: one-time blood draw, rewiev of medical history
  •   patients with coronary artery disease and type 2 diabetes: one-time blood draw, rewiev of medical history
  •   patients with acute coronary syndrome: 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

Phenotype of peripheral blood leukocytes

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Secondary Outcome

Intracellular signalling cascades

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/12/15
  •   240
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Age between 18 and 75
Group 1: healthy, no known cardiac disease, no diabetes
Group 2: stable coronary artery disease, no diabetes
Group 3: stable coronary artery disease and type 2 diabetes
Group 4: patients with acute coronary syndrome

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Exclusion Criteria

All participants
1. pregnancy
2. renal failure (creatinin >265umol)
3. liver failure
4. hematologic diseases
5. malignancy within the last 5 years (no evidence of relapse at the time of inclusion)
6. acute or chronic inflammatory disease
7. patient is unable to give informed consent
8. organ transplantation in history
9. acute shock
10. diabetes mellitus type 1
11. metabolic diseases such as heriditary lipometabolic disorders
12. in all groups except the type 2 diabetes group: type 2 diabetes

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Addresses

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    • 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.  Kira  Kuschnerus 
    • 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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    • Charité Universitätsmedizin BerlinKlinik für KardiologieCampus Benjamin Franklin
    • Mr.  Prof. Dr.  Ulf  Landmesser 
    • 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.