Coronary Artery DiseaseNCT02265016
Regulation and Signaling of Red Blood Cell (RBC) Endothelial Nitric Oxide Synthase (eNOS) in Patients With Stable and Unstable Coronary Artery Disease
An observational study of Coronary Artery Disease and Endothelial NO-synthase, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The aim of this study is measurement of expression and activity of RBC eNOS in different clinical cohorts of patients with coronary artery disease and acute coronary syndrome and to investigate the importance of the NO-stimulated reaction cascade in terms of sGC and PKG. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Endothelial NO-synthase
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3 groups: * ACS group (100 Patients) * stable CAD group (100 Patients) * healthy control group (100 Healthy Volunteers)
Who may be able to join
- informed consent
- for ACS(acute coronary syndrome)-Group: angiographic coronary artery disease; acute coronary syndrome, defined by EITHER unstable angina pectoris with significant coronary stenosis (troponin negative, without significant ST-elevation) OR low-risk NSTEMI (Troponin positive, without significant ST-elevation)
- for stable CAD-Group: angiographic coronary artery disease; no acute coronary syndrome within the last 3 months
- healthy control group: No clinical or angiographical signs of apparent atherosclerosis
Who cannot join
- acute inflammation (CRP > 1 mg/dl, leukocyte > 11.000/µl)
- malignant diseases
- pregnancy
- medication with NO-donors ( e.g.isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate, Molsidomin, Ranexa)
- patients with STEMI or high-risk NSTEMI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulation and Signaling of RBC-eNOS in Patients With Stable and Unstable Coronary Artery Disease
The aim of this study is measurement of expression and activity of RBC eNOS in different clinical cohorts of patients with coronary artery disease and acute coronary syndrome and to investigate the importance of the NO-stimulated reaction cascade in terms of sGC and PKG.
- Conditions
- Coronary Artery Disease, Endothelial NO-synthase
- Keywords
- coronary artery disease, acute coronary syndrome, angina pectoris, non-ST-segment elevation myocardial infarction, red blood cells, erythrocytes
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Angina Pectoris
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 |
|---|---|---|
| Patients with CAD | Patients with stable coronary artery disease | |
| Patients with ACS | Patients with acute coronar syndrome, instable Angina pectoris and low-risk NSTEMI | |
| healthy control group | healthy control group without clinical apparent arteriosclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of red cell endothelial nitric oxide-synthase (eNOS)-expression and - activity
Measured: baseline, 3 hours and 3 month
Secondary outcomes (17)
Deformability and stability of red blood cell membrane
by Laser assisted Optical Rotational Cell Analyzer (LORCA)
Measured: baseline, 3 hours and 3 month
Microvascular function
Determination of microvascular function with Laser-Doppler Perfusion Imaging
Measured: baseline, 3 hours and 3 month
Peripheral and central hemodynamic measurement
Measured: baseline, 3 hours and 3 month
Determination of arterial stiffness
Determination of arterial stiffness with pulse wave analysis during blood pressure measurement or echocardiography.
Measured: baseline, 3 hours and 3 month
determination of flow-mediated dilation
Measured: baseline, 3 hours and 3 month
Determination of nitrate and nitrite in blood plasma and red blood cells (RBC)
Measured: baseline, 3 hours and 3 month
Determination of nitric oxide and cyclic guanosine monophosphate (cGMP) in blood plasma and in red blood cells
Measured: baseline, 3 hours and 3 month
Determination of endothelial microparticles
Measured: baseline, 3 hours and 3 month
Electrocardiogram
Measured: baseline, 3 hours and 3 month
Aging and turnover of red blood cells
Measured: baseline, 3 hours and 3 month
Redox status of red blood cells
Determination of redox status of red blood cells will be measured on free thiole with thioltracker and reactive oxygen species( ROS) by dihydrodichlorofluorescein
Measured: baseline, 3 hours and 3 month
Aggregation of red blood cells
Determination of aggregation of red blood cells with LORCA
Measured: baseline, 3 hours and 3 month
Platelet aggregometry
Measured: baseline, 3 hours and 3 month
Expression and function of soluble guanylyl cyclase (sGC) in red blood cells
measurement of enzyme expression and activity
Measured: baseline, 3 hours and 3 month
Expression and activity of Protein Kinase G (PKG)
measurement of enzyme expression and activity
Measured: baseline, 3 hours and 3 month
Determination of leucocyte populations and leucocyte function
flow-cytometry
Measured: baseline, 3 hours and 3 month
Changes of tetrahydrobiopterin-metabolism
Measured: baseline, 3 hours and 3 month
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 startJan 2014
- 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 Coronary Artery DiseaseStudies 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
- Other
- Enrolment
- 300 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
- NCT02265016
- Sponsor's protocol ID
- RBC in CAD
- Other IDs
- 13-037
- 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
- Regulation and Signaling of RBC-eNOS in Patients With Stable and Unstable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02265016
- Acronym / sponsor ID
- RBC in CAD
- Conditions
- Coronary Artery Disease, Endothelial NO-synthase
- Keywords
- coronary artery disease, acute coronary syndrome, angina pectoris, non-ST-segment elevation myocardial infarction, red blood cells, erythrocytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jan 2014
- 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 measurement of expression and activity of RBC eNOS in different clinical cohorts of patients with coronary artery disease and acute coronary syndrome and to investigate the importance of the NO-stimulated reaction cascade in terms of sGC and PKG.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with CAD | – | –Patients with stable coronary artery disease |
| Patients with ACS | – | –Patients with acute coronar syndrome, instable Angina pectoris and low-risk NSTEMI |
| healthy control group | – | –healthy control group without clinical apparent arteriosclerosis |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3 groups: * ACS group (100 Patients) * stable CAD group (100 Patients) * healthy control group (100 Healthy Volunteers)
Key inclusion criteria (4 listed)
- informed consent
- for ACS(acute coronary syndrome)-Group: angiographic coronary artery disease; acute coronary syndrome, defined by EITHER unstable angina pectoris with significant coronary stenosis (troponin negative, without significant ST-elevation) OR low-risk NSTEMI (Troponin positive, without significant ST-elevation)
- for stable CAD-Group: angiographic coronary artery disease; no acute coronary syndrome within the last 3 months
- healthy control group: No clinical or angiographical signs of apparent atherosclerosis
Key exclusion criteria (5 listed)
- acute inflammation (CRP > 1 mg/dl, leukocyte > 11.000/µl)
- malignant diseases
- pregnancy
- medication with NO-donors ( e.g.isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate, Molsidomin, Ranexa)
- patients with STEMI or high-risk NSTEMI
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 red cell endothelial nitric oxide-synthase (eNOS)-expression and - activity
Time frame: baseline, 3 hours and 3 month
17 secondary outcomes
Deformability and stability of red blood cell membrane
Time frame: baseline, 3 hours and 3 month
Microvascular function
Time frame: baseline, 3 hours and 3 month
Peripheral and central hemodynamic measurement
Time frame: baseline, 3 hours and 3 month
Determination of arterial stiffness
Time frame: baseline, 3 hours and 3 month
determination of flow-mediated dilation
Time frame: baseline, 3 hours and 3 month
Determination of nitrate and nitrite in blood plasma and red blood cells (RBC)
Time frame: baseline, 3 hours and 3 month
Determination of nitric oxide and cyclic guanosine monophosphate (cGMP) in blood plasma and in red blood cells
Time frame: baseline, 3 hours and 3 month
Determination of endothelial microparticles
Time frame: baseline, 3 hours and 3 month
Electrocardiogram
Time frame: baseline, 3 hours and 3 month
Aging and turnover of red blood cells
Time frame: baseline, 3 hours and 3 month
Redox status of red blood cells
Time frame: baseline, 3 hours and 3 month
Aggregation of red blood cells
Time frame: baseline, 3 hours and 3 month
Platelet aggregometry
Time frame: baseline, 3 hours and 3 month
Expression and function of soluble guanylyl cyclase (sGC) in red blood cells
Time frame: baseline, 3 hours and 3 month
Expression and activity of Protein Kinase G (PKG)
Time frame: baseline, 3 hours and 3 month
Determination of leucocyte populations and leucocyte function
Time frame: baseline, 3 hours and 3 month
Changes of tetrahydrobiopterin-metabolism
Time frame: baseline, 3 hours and 3 month
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 Coronary Artery Disease and Endothelial NO-synthase, 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 5 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 red cell endothelial nitric oxide-synthase (eNOS)-expression and - activity (time frame: baseline, 3 hours and 3 month). 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.