Red Blood CellNCT02272530
Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells
An observational study of Red Blood Cell and Peripheral Blood Mononuclear Cell, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The aim of this study is to investigate wether change in endothelial nitric oxid synthase of blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on development and progression of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Red Blood Cell, Peripheral Blood Mononuclear Cell, Endothelial NO-synthase
- How many people
- 200 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 healthy volunteers and 100 patient with stable coronary artery disease
Who may be able to join
- healthy volunteers
- Patients: stable coronary artery disease with accordingly endothelial dysfunction
Who cannot join
- acute inflammation (CRP>0,5 mg/dl, leucocyte >11000/dl)
- malignant diseases
- acute or terminated kidney disease
- relevant heart failure (NYHA III-IV)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate wether change in endothelial nitric oxid synthase of blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on development and progression of cardiovascular diseases.
- Keywords
- Endothelial NO-synthase, red blood cell, erythrocytes, Peripheral Blood Mononuclear Cell, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
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 | 100 healthy volunteers in age of 20-75 years | |
| Patients | 100 patients with stable coronary artery disease and accordingly endothelial dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood examination
Following parameters will be examined:
- Blood count (red cells, white cells, platelets, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red blood cell distribution width (RDW), mean platelet volume (MPV) )
- Creatinin
- Urea
- Glucose
- Glycated hemoglobin (HbA1c)
- Cholesterol
- Triglyceride
- C-reactive Protein
- Apolipoprotein
Measured: baseline
Secondary outcomes (6)
Protein expression
Determination with western blot
Measured: baseline
Asymmetric dimethylarginine (ADMA) and Cytokine
Determination with enzyme-linked immunosorbent assay (ELISA).
Measured: baseline
Microparticles
Determination with ELISA and flow cytometry
Measured: baseline
Immunocytochemistry
Measured: baseline
Nitric oxid metabolite and proteins in blood plasma, red blood cells and peripheral blood mononuclear cells (PBMN)
Determination with reductive chemiluminescence
Measured: baseline
Nitric oxid and reactive oxygen species
Determination with fluorescence coloring in flow cytometry and fluorescence microscopy
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 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 CellStudies 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
- 200 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
- NCT02272530
- Sponsor's protocol ID
- Proteome
- Status last verified
- Feb 2021
- First submitted
- 21 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
- Analysis of Proteome and Pathophysiological Characteristics of Human Blood Cells
- ClinicalTrials.gov ID
- NCT02272530
- Acronym / sponsor ID
- Proteome
- Keywords
- Endothelial NO-synthase, red blood cell, erythrocytes, Peripheral Blood Mononuclear Cell, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 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
- 23 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 investigate wether change in endothelial nitric oxid synthase of blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on development and progression of cardiovascular diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –100 healthy volunteers in age of 20-75 years |
| Patients | – | –100 patients with stable coronary artery disease and accordingly endothelial dysfunction |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 healthy volunteers and 100 patient with stable coronary artery disease
Key inclusion criteria (2 listed)
- healthy volunteers
- Patients: stable coronary artery disease with accordingly endothelial dysfunction
Key exclusion criteria (4 listed)
- acute inflammation (CRP>0,5 mg/dl, leucocyte >11000/dl)
- malignant diseases
- acute or terminated kidney disease
- relevant heart failure (NYHA III-IV)
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
Blood examination
Time frame: baseline
Following parameters will be examined: * Blood count (red cells, white cells, platelets, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red blood cell distribution width (RDW), mean platelet volume (MPV) ) * Creatinin * Urea * Glucose * Glycated hemoglobin (HbA1c) * Cholesterol * Triglyceride * C-reactive Protein * Apolipoprotein
6 secondary outcomes
Protein expression
Time frame: baseline
Asymmetric dimethylarginine (ADMA) and Cytokine
Time frame: baseline
Microparticles
Time frame: baseline
Immunocytochemistry
Time frame: baseline
Nitric oxid metabolite and proteins in blood plasma, red blood cells and peripheral blood mononuclear cells (PBMN)
Time frame: baseline
Nitric oxid and reactive oxygen species
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 Cell and Peripheral Blood Mononuclear Cell, 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 2 inclusion and 4 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?
Blood examination (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.