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Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272530
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Brief Summary:
The aim of this study is to investigate wether change in endothelial nitric oxid synthase of blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on development and progression of cardiovascular diseases.

Condition or disease
Red Blood Cell Peripheral Blood Mononuclear Cell Endothelial NO-synthase

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells
Study Start Date : July 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort
Healthy
100 healthy volunteers in age of 20-75 years
Patients
100 patients with stable coronary artery disease and accordingly endothelial dysfunction



Primary Outcome Measures :
  1. Blood examination [ Time Frame: baseline ]

    Following parameters will be examined:

    • Blood count (red cells, white cells, platelets, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red blood cell distribution width (RDW), mean platelet volume (MPV) )
    • Creatinin
    • Urea
    • Glucose
    • Glycated hemoglobin (HbA1c)
    • Cholesterol
    • Triglyceride
    • C-reactive Protein
    • Apolipoprotein


Secondary Outcome Measures :
  1. Protein expression [ Time Frame: baseline ]
    Determination with western blot

  2. Asymmetric dimethylarginine (ADMA) and Cytokine [ Time Frame: baseline ]
    Determination with enzyme-linked immunosorbent assay (ELISA).

  3. Microparticles [ Time Frame: baseline ]
    Determination with ELISA and flow cytometry

  4. Immunocytochemistry [ Time Frame: baseline ]
  5. Nitric oxid metabolite and proteins in blood plasma, red blood cells and peripheral blood mononuclear cells (PBMN) [ Time Frame: baseline ]
    Determination with reductive chemiluminescence

  6. Nitric oxid and reactive oxygen species [ Time Frame: baseline ]
    Determination with fluorescence coloring in flow cytometry and fluorescence microscopy


Biospecimen Retention:   Samples Without DNA
Blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
100 healthy volunteers and 100 patient with stable coronary artery disease
Criteria

Inclusion Criteria:

  • healthy volunteers
  • Patients: stable coronary artery disease with accordingly endothelial dysfunction

Exclusion Criteria:

  • acute inflammation (CRP>0,5 mg/dl, leucocyte >11000/dl)
  • malignant diseases
  • acute or terminated kidney disease
  • relevant heart failure (NYHA III-IV)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272530


Locations
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Germany
University Hospital Duesseldorf
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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Principal Investigator: Malte Kelm, Prof. MD Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf

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Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02272530    
Other Study ID Numbers: Proteome
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Keywords provided by Heinrich-Heine University, Duesseldorf:
Endothelial NO-synthase
red blood cell
erythrocytes
Peripheral Blood Mononuclear Cell
cardiovascular disease