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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02272530
Other study ID # Proteome
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2012
Est. completion date December 31, 2020

Study information

Verified date February 2021
Source Heinrich-Heine University, Duesseldorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital Duesseldorf Duesseldorf

Sponsors (1)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
baseline
Secondary Protein expression Determination with western blot baseline
Secondary Asymmetric dimethylarginine (ADMA) and Cytokine Determination with enzyme-linked immunosorbent assay (ELISA). baseline
Secondary Microparticles Determination with ELISA and flow cytometry baseline
Secondary Immunocytochemistry baseline
Secondary Nitric oxid metabolite and proteins in blood plasma, red blood cells and peripheral blood mononuclear cells (PBMN) Determination with reductive chemiluminescence baseline
Secondary Nitric oxid and reactive oxygen species Determination with fluorescence coloring in flow cytometry and fluorescence microscopy baseline
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