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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02265003
Other study ID # Anaemie
Secondary ID 14-016
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 find out, how far red blood cells reflect age-depended changes in endothelial function.


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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 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 Determination of endothelial function measured as flow-mediated vasodilation baseline
Secondary Determination of nitric oxide(NO)-pool in red blood cells and blood plasma baseline
Secondary 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
Secondary Cardiovascular Parameter It will be determinated: hemodynamic, microcirculation and physicomechanic baseline
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