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.

Study Overview

• Status: Completed
• Conditions: Endothelial Function; Red Blood Cells; Nitric Oxide Pool in Red Blood Cells and Blood Plasma

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

4 groups:

• healthy young aged 18-35 years (30 subjects)
• healthy middel aged 35-45 years (30 subjects)
• healthy old aged > 70 years (30 subjects)
• patients (50 subjects)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Healthy young age; Healthy subjects in age of 18-35 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease
Healthy middle age; Healthy subjects in age of 35-45 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease
Healthy old; Healthy subjects in age of >70 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease
Patients; Patients with atherosclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of endothelial function	measured as flow-mediated vasodilation	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of nitric oxide(NO)-pool in red blood cells and blood plasma		baseline
Determination of erythrocytes parameter	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	baseline
Cardiovascular Parameter	It will be determinated: hemodynamic, microcirculation and physicomechanic	baseline

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: Malte Kelm, Prof. MD, Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf

Study record dates

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 9, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 15, 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: endothelial function; red blood cells; oxidative status; nitric oxide pool in red blood cells; nitric oxide poll in blood plasma; nitric oxide synthase III - expression; nitric oxide signalling
• Other Study ID Numbers: Anaemie; 14-016 (CTSU)