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OpenTrials
Completed

NCT Number: NCT02265003

Red Blood Cells as a Reflection of Endothelial Function in Old Age

The aim of this study is to find out, how far red blood cells reflect age-depended changes in endothelial function.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

About this study

It will be investigated with determination of endothelial function (measured as flow-mediated vasodilation) and of circulated nitric oxid-pool in red blood cells and in blood plasma, how far red blood cells reflect age-depended changes in endothelial function.

Who can participate

Healthy volunteers accepted: Yes

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

Groups 1-3:

Inclusion criteria

  • healthy subjects
  • informed consent

Exclusion criteria

  • hypertension (blood pressure ≥140/90 mmHg),
  • hypercholesterolemia (LDL ≥250 mg/dl, HDL ≤45 mg/dl),
  • diabetes mellitus (fasting plasma glucose ≥128 mg/dl)
  • acute inflammation (CRP >0.5 mg/dl)
  • malignant diseases
  • heart failure (NYHA III-IV)
  • arrhythmia of high degree
  • acute or terminated kidney disease
  • cardiovascular diseases ( cardiac artery disease, peripheral vascular disease and cerebrovascular diseases)
  • anemia
  • pregnancy

Group 4 :

Inclusion criteria

  • angiographical signs of apparent atherosclerosis (cardiac artery disease or peripheral vascular disease or degenerative valvular heart disease)
  • informed consent

Exclusion criteria

  • Hypertension (blood pressure ≥140/90 mmHg),
  • Hypercholesterolemia (LDL ≥250 mg/dl, HDL ≤45 mg/dl),
  • Diabetes mellitus (fasting plasma glucose ≥128 mg/dl)
  • acute inflammation (CRP >0.5 mg/dl)
  • malignant diseases
  • heart failure (NYHA III-IV)
  • arrhythmia of high degree
  • acute or terminated kidney disease
  • cardiovascular diseases ( cardiac artery disease, peripheral vascular disease and cerebrovascular diseases)
  • anemia
  • pregnancy

Treatment and study plan

Primary outcomes

  1. Determination of endothelial function

    Time frame: baseline

    measured as flow-mediated vasodilation

Secondary outcomes

  1. Determination of nitric oxide(NO)-pool in red blood cells and blood plasma

    Time frame: baseline

  2. Determination of erythrocytes parameter

    Time frame: baseline

    It will be determinated: oxidative status, signalling of nitric oxide, function, creation, amount and aging of red blood cells, cell-to-cell-interaction, microRNA and inflammation

  3. Cardiovascular Parameter

    Time frame: baseline

    It will be determinated: hemodynamic, microcirculation and physicomechanic

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 15, 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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