Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells

February 15, 2021 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • University Hospital Duesseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

100 healthy volunteers and 100 patient with stable coronary artery disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Malte Kelm, Prof. MD, Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Proteome

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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