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CompletedNCT02272530Updated Feb 16, 2021

Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells

An observational study in Red Blood Cell, Peripheral Blood Mononuclear Cell and Endothelial NO-synthase, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 1 site in Germany. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by Heinrich-Heine University, Duesseldorf · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Red Blood Cell
  • Peripheral Blood Mononuclear Cell
  • Endothelial NO-synthase

Keywords

  • Endothelial NO-synthase
  • red blood cell
  • erythrocytes
  • Peripheral Blood Mononuclear Cell
  • cardiovascular disease
03

In context

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

100 healthy volunteers and 100 patient with stable coronary artery disease

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Healthy

    100 healthy volunteers in age of 20-75 years

  • Patients

    100 patients with stable coronary artery disease and accordingly endothelial dysfunction

06

What researchers measure

Primary outcomes

  1. Blood examination

    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

    Time frame: baseline

Secondary outcomes

  1. Protein expression

    Determination with western blot

    Time frame: baseline

  2. Asymmetric dimethylarginine (ADMA) and Cytokine

    Determination with enzyme-linked immunosorbent assay (ELISA).

    Time frame: baseline

  3. Microparticles

    Determination with ELISA and flow cytometry

    Time frame: baseline

  4. Immunocytochemistry

    Time frame: baseline

  5. Nitric oxid metabolite and proteins in blood plasma, red blood cells and peripheral blood mononuclear cells (PBMN)

    Determination with reductive chemiluminescence

    Time frame: baseline

  6. Nitric oxid and reactive oxygen species

    Determination with fluorescence coloring in flow cytometry and fluorescence microscopy

    Time frame: baseline

07

Study locations

1 site
  • University Hospital Duesseldorf
    Duesseldorf, 40225, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02272530
Lead sponsor
Heinrich-Heine University, Duesseldorf
Responsible party
Klinik für Kardiologie, Pneumologie und Angiologie (Principle Investigator Prof. Dr. Malte Kelm, Heinrich-Heine University, Duesseldorf) — Principal investigator
First posted
Oct 23, 2014
Start date
Jul 2012
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Feb 16, 2021

Study contacts

Malte Kelm, Prof. MD
principal investigator · Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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