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

Endothelial Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265003
• Other study ID #: Anaemie
• Secondary ID: 14-016
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Endothelial Function
• Nitric Oxide Pool in Red Blood Cells and Blood Plasma
• Red Blood Cells

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