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

NCT02265016 | Completed

• 2 other identifiers: RBC in CAD13-037
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

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

  baseline, 3 hours and 3 month

Secondary Outcomes (17)

• Deformability and stability of red blood cell membrane

  baseline, 3 hours and 3 month

• Microvascular function

  baseline, 3 hours and 3 month

• Peripheral and central hemodynamic measurement

  baseline, 3 hours and 3 month

• Determination of arterial stiffness

  baseline, 3 hours and 3 month

• determination of flow-mediated dilation

  baseline, 3 hours and 3 month

Study Arms (3)

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3 groups: * ACS group (100 Patients) * stable CAD group (100 Patients) * healthy control group (100 Healthy Volunteers)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Malte Kelm, Prof. MD

  Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator Prof. Dr. Malte Kelm

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 15, 2014
• Study Start: January 1, 2014
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

DE (1)