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

NCT02265003 | Completed

• 2 other identifiers: Anaemie14-016
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Determination of endothelial function

  measured as flow-mediated vasodilation

  baseline

Secondary Outcomes (3)

• Determination of nitric oxide(NO)-pool in red blood cells and blood plasma

  baseline

• Determination of erythrocytes parameter

  baseline

• Cardiovascular Parameter

  baseline

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• healthy subjects
• informed consent

You may not qualify if:

• 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 :
• angiographical signs of apparent atherosclerosis (cardiac artery disease or peripheral vascular disease or degenerative valvular heart disease)
• informed consent
• Hypertension (blood pressure ≥140/90 mmHg),

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

Study Officials

• Malte Kelm, Prof. MD

  Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator Prof. Dr. Malte Kelm

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 15, 2014
• Study Start: July 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

DE (1)