Endothelial Function Clinical Trial
Official title:
Red Blood Cells as a Reflection of Endothelial Function in Old Age
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 |
Verified date | February 2021 |
Source | Heinrich-Heine University, Duesseldorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to find out, how far red blood cells reflect age-depended changes in endothelial function.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Duesseldorf | Duesseldorf |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf |
Germany,
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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