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OpenTrials
Completed

NCT Number: NCT02393768

Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud university medical center

Nijmegen, 6500 GA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. Epigenetic modifications in circulating monocytes

    Time frame: baseline

Secondary outcomes

  1. Inflammatory phenotype

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Canisius-Wilhelmina Hospital

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 19, 2015
Registry last updated
Apr 22, 2016

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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