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Completed

NCT Number: NCT03354156

The Effect of Statin Treatment on Trained Innate Immunity

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, in particular trimethylation of lysine 4 at histone 3 (H3K4me3).

In this study, the investigators aim to investigate the immunophenotype of circulating monocytes in patients with elevated LDL cholesterol levels and the effect of statins on this phenotype.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

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

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, in particular trimethylation of lysine 4 at histone 3 (H3K4me3).

The main objective is to study whether circulating monocytes of patients with elevated levels of LDL have a phenotype of trained innate immunity compared to control patients. Subsequently the investigators will study the effect of treatment with statins on the increased inflammatory response and epigenetic changes of the innate immune system.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 years or older
  • Elevated LDL levels (>4.9 mmol/l)
  • Decision made by treating physician to initiate statin treatment

Exclusion criteria

  • previous cardiovascular events.

Treatment and study plan

statin treatment

Drug

The patients with elevated LDL receive statin treatment in the context of normal patient care (so this is NOT an intervention of the study)

Primary outcomes

  1. Cytokine production capacity

    Time frame: baseline

    Cytokine production capacity of PBMC's at baseline in patients with elevated and normal cholesterol levels

Secondary outcomes

  1. Cytokine production capacity

    Time frame: Three months after start of statin treatment

    Cytokine production capacity of PBMC's at baseline in patients with elevated and normal cholesterol levels

  2. Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.

    Time frame: baseline

    Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.

  3. Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.

    Time frame: Three months after start of statin treatment

    Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • AIDS Malignancy Consortium
  • Erasmus Medical Center

Registry information

Official study title

Effect of Statins on Epigenetic Reprogramming of Monocytes in Patients With Elevated Levels of LDL

Acronym: SIMPEL

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2017
Registry last updated
Nov 27, 2017

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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