Red Blood CellsNCT02265003
Red Blood Cells as a Reflection of Endothelial Function in Old Age
An observational study of Red Blood Cells and Endothelial Function, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The aim of this study is to find out, how far red blood cells reflect age-depended changes in endothelial function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Red Blood Cells, Endothelial Function, Nitric Oxide Pool in Red Blood Cells and Blood Plasma
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- healthy subjects
- informed consent
- angiographical signs of apparent atherosclerosis (cardiac artery disease or peripheral vascular disease or degenerative valvular heart disease)
- informed consent
Who cannot join
- 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)
Show all 23Show fewer
- arrhythmia of high degree
- acute or terminated kidney disease
- cardiovascular diseases ( cardiac artery disease, peripheral vascular disease and cerebrovascular diseases)
- anemia
- pregnancy
- Group 4 :
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to find out, how far red blood cells reflect age-depended changes in endothelial function.
Read the 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of endothelial function
measured as flow-mediated vasodilation
Measured: baseline
Secondary outcomes (3)
Determination of nitric oxide(NO)-pool in red blood cells and blood plasma
Measured: baseline
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
Measured: baseline
Cardiovascular Parameter
It will be determinated: hemodynamic, microcirculation and physicomechanic
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJul 2012
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Red Blood CellsStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Malte Kelm, Prof. MD, Principal investigator, Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265003
- Sponsor's protocol ID
- Anaemie
- Other IDs
- 14-016
- Status last verified
- Feb 2021
- First submitted
- 9 Oct 2014
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cells as a Reflection of Endothelial Function in Old Age
- ClinicalTrials.gov ID
- NCT02265003
- Acronym / sponsor ID
- Anaemie
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- healthy subjects
- informed consent
- angiographical signs of apparent atherosclerosis (cardiac artery disease or peripheral vascular disease or degenerative valvular heart disease)
- informed consent
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of endothelial function
Time frame: baseline
measured as flow-mediated vasodilation
3 secondary outcomes
Determination of nitric oxide(NO)-pool in red blood cells and blood plasma
Time frame: baseline
Determination of erythrocytes parameter
Time frame: baseline
Cardiovascular Parameter
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malte Kelm, Prof. MD principal investigator
Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Red Blood Cells and Endothelial Function, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of endothelial function (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.