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NCT Number: NCT02265016

Regulation and Signaling of Red Blood Cell (RBC) Endothelial Nitric Oxide Synthase (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.

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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Endothelial NO-synthase Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determination of red cell endothelial nitric oxide-synthase (eNOS)-expression and - activity

    Time frame: baseline, 3 hours and 3 month

Secondary outcomes

  1. Deformability and stability of red blood cell membrane

    Time frame: baseline, 3 hours and 3 month

    by Laser assisted Optical Rotational Cell Analyzer (LORCA)

  2. Microvascular function

    Time frame: baseline, 3 hours and 3 month

    Determination of microvascular function with Laser-Doppler Perfusion Imaging

  3. Peripheral and central hemodynamic measurement

    Time frame: baseline, 3 hours and 3 month

  4. 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.

  5. determination of flow-mediated dilation

    Time frame: baseline, 3 hours and 3 month

  6. Determination of nitrate and nitrite in blood plasma and red blood cells (RBC)

    Time frame: baseline, 3 hours and 3 month

  7. 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

  8. Determination of endothelial microparticles

    Time frame: baseline, 3 hours and 3 month

  9. Electrocardiogram

    Time frame: baseline, 3 hours and 3 month

  10. Aging and turnover of red blood cells

    Time frame: baseline, 3 hours and 3 month

  11. 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

  12. Aggregation of red blood cells

    Time frame: baseline, 3 hours and 3 month

    Determination of aggregation of red blood cells with LORCA

  13. Platelet aggregometry

    Time frame: baseline, 3 hours and 3 month

  14. 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

  15. Expression and activity of Protein Kinase G (PKG)

    Time frame: baseline, 3 hours and 3 month

    measurement of enzyme expression and activity

  16. Determination of leucocyte populations and leucocyte function

    Time frame: baseline, 3 hours and 3 month

    flow-cytometry

  17. Changes of tetrahydrobiopterin-metabolism

    Time frame: baseline, 3 hours and 3 month

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Regulation and Signaling of RBC-eNOS in Patients With Stable and Unstable Coronary Artery Disease

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2014
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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