Regulation and Signaling of Red Blood Cell (RBC) Endothelial Nitric Oxide Synthase (eNOS) in Patients With Stable and Unstable Coronary Artery Disease

February 15, 2021 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • University Hospital Duesseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

3 groups:

  • ACS group (100 Patients)
  • stable CAD group (100 Patients)
  • healthy control group (100 Healthy Volunteers)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Determination of red cell endothelial nitric oxide-synthase (eNOS)-expression and - activity
Time Frame: baseline, 3 hours and 3 month
baseline, 3 hours and 3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Deformability and stability of red blood cell membrane
Time Frame: baseline, 3 hours and 3 month
by Laser assisted Optical Rotational Cell Analyzer (LORCA)
baseline, 3 hours and 3 month
Microvascular function
Time Frame: baseline, 3 hours and 3 month
Determination of microvascular function with Laser-Doppler Perfusion Imaging
baseline, 3 hours and 3 month
Peripheral and central hemodynamic measurement
Time Frame: baseline, 3 hours and 3 month
baseline, 3 hours and 3 month
Determination of arterial stiffness
Time Frame: baseline, 3 hours and 3 month
Determination of arterial stiffness with pulse wave analysis during blood pressure measurement or echocardiography.
baseline, 3 hours and 3 month
determination of flow-mediated dilation
Time Frame: baseline, 3 hours and 3 month
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
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
baseline, 3 hours and 3 month
Determination of endothelial microparticles
Time Frame: baseline, 3 hours and 3 month
baseline, 3 hours and 3 month
Electrocardiogram
Time Frame: baseline, 3 hours and 3 month
baseline, 3 hours and 3 month
Aging and turnover of red blood cells
Time Frame: baseline, 3 hours and 3 month
baseline, 3 hours and 3 month
Redox status of red blood cells
Time Frame: baseline, 3 hours and 3 month
Determination of redox status of red blood cells will be measured on free thiole with thioltracker and reactive oxygen species( ROS) by dihydrodichlorofluorescein
baseline, 3 hours and 3 month
Aggregation of red blood cells
Time Frame: baseline, 3 hours and 3 month
Determination of aggregation of red blood cells with LORCA
baseline, 3 hours and 3 month
Platelet aggregometry
Time Frame: baseline, 3 hours and 3 month
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
measurement of enzyme expression and activity
baseline, 3 hours and 3 month
Expression and activity of Protein Kinase G (PKG)
Time Frame: baseline, 3 hours and 3 month
measurement of enzyme expression and activity
baseline, 3 hours and 3 month
Determination of leucocyte populations and leucocyte function
Time Frame: baseline, 3 hours and 3 month
flow-cytometry
baseline, 3 hours and 3 month
Changes of tetrahydrobiopterin-metabolism
Time Frame: baseline, 3 hours and 3 month
baseline, 3 hours and 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heinrich-Heine University, Duesseldorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Malte Kelm, Prof. MD, Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBC in CAD
  • 13-037 (Other Identifier: CTSU)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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