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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265016
• Other study ID #: RBC in CAD
• Secondary ID: 13-037
• Status: Completed
• Start date: January 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Endothelial NO-synthase
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	University Hospital Duesseldorf	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of red cell endothelial nitric oxide-synthase (eNOS)-expression and - activity		baseline, 3 hours and 3 month
Secondary	Deformability and stability of red blood cell membrane	by Laser assisted Optical Rotational Cell Analyzer (LORCA)	baseline, 3 hours and 3 month
Secondary	Microvascular function	Determination of microvascular function with Laser-Doppler Perfusion Imaging	baseline, 3 hours and 3 month
Secondary	Peripheral and central hemodynamic measurement		baseline, 3 hours and 3 month
Secondary	Determination of arterial stiffness	Determination of arterial stiffness with pulse wave analysis during blood pressure measurement or echocardiography.	baseline, 3 hours and 3 month
Secondary	determination of flow-mediated dilation		baseline, 3 hours and 3 month
Secondary	Determination of nitrate and nitrite in blood plasma and red blood cells (RBC)		baseline, 3 hours and 3 month
Secondary	Determination of nitric oxide and cyclic guanosine monophosphate (cGMP) in blood plasma and in red blood cells		baseline, 3 hours and 3 month
Secondary	Determination of endothelial microparticles		baseline, 3 hours and 3 month
Secondary	Electrocardiogram		baseline, 3 hours and 3 month
Secondary	Aging and turnover of red blood cells		baseline, 3 hours and 3 month
Secondary	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	baseline, 3 hours and 3 month
Secondary	Aggregation of red blood cells	Determination of aggregation of red blood cells with LORCA	baseline, 3 hours and 3 month
Secondary	Platelet aggregometry		baseline, 3 hours and 3 month
Secondary	Expression and function of soluble guanylyl cyclase (sGC) in red blood cells	measurement of enzyme expression and activity	baseline, 3 hours and 3 month
Secondary	Expression and activity of Protein Kinase G (PKG)	measurement of enzyme expression and activity	baseline, 3 hours and 3 month
Secondary	Determination of leucocyte populations and leucocyte function	flow-cytometry	baseline, 3 hours and 3 month
Secondary	Changes of tetrahydrobiopterin-metabolism		baseline, 3 hours and 3 month