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Completed

NCT Number: NCT02272530

Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells

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.

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Key information

Conditions

Red Blood Cell Cardiovascular Diseases Endothelial NO-synthase Peripheral Blood Mononuclear Cell

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2014
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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