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NCT02393768 Clinical Trial

Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis

Atherosclerosis Clinical Trial

Official title:
Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02393768
Other study ID # SB EpiCard
Secondary ID
Status Recruiting
Phase N/A
First received March 13, 2015
Last updated March 18, 2015
Start date October 2014

Study information
Verified date March 2015
Source Radboud University
Contact Niels Riksen, MD, PhD
Phone 0031-24-3618819
Email niels.riksen@radboudumc.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

In this study, the investigators will determine whether patients with documented atherosclerosis are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to patients without atherosclerosis.

Description:

Rationale: The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming. We hypothesize that trained monocytes augment atherogenesis.

Objective: The main objective is to study whether patients with coronary atherosclerosis show specific epigenetic changes in the promoter regions of pro-inflammatory cytokines and chemokines and whether this correlates with the inflammatory phenotype of these cells.

Study design: Observational study

Study population: Adult patients who have had computed tomography coronary angiography because of chest pain: 20 patients without atherosclerosis and 20 patients with severe atherosclerosis will be included.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients (male/female),

- aged >18 years,

- admitted to the acute coronary unit of the CWZ hospital for evaluation of chest pain.

- No coronary atherosclerosis

- Or Severe atherosclerosis

Exclusion Criteria:

- Signs or symptoms of a current infection (fever, chills)

- Auto-immune diseases (such as rheumatoid arthritis)

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Radboud university medical center Nijmegen

Sponsors (2)
Lead Sponsor Collaborator
Radboud University Canisius-Wilhelmina Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Epigenetic modifications in circulating monocytes baseline No
Secondary Inflammatory phenotype baseline No
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