Clinical trial NCT02265003: Red Blood Cells as a Reflection of Endothelial Function in Old Age
Official title: Red Blood Cells as a Reflection of Endothelial Function in Old Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Red Blood Cells
Endothelial Function
Nitric Oxide Pool in Red Blood Cells and Blood Plasma
Keywords: red blood cells
endothelial function
nitric oxide pool in red blood cells
nitric oxide poll in blood plasma
nitric oxide synthase III - expression
oxidative status
nitric oxide signalling
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of endothelial function
timeFrame: baseline
Secondary outcomes:
measure: Determination of nitric oxide(NO)-pool in red blood cells and blood plasma
timeFrame: baseline
measure: Determination of erythrocytes parameter
timeFrame: baseline
measure: Cardiovascular Parameter
timeFrame: baseline
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: University Hospital Duesseldorf
Study officials:
affiliation: Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf
name: Malte Kelm, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: