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

Completed

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

• Registration Number: NCT02265003
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-15
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of endothelial function	baseline	measured as flow-mediated vasodilation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Duesseldorf; 🇩🇪 Duesseldorf, Germany