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The Effect of Statin Treatment on Trained Innate Immunity (SIMPEL)

R

Radboud University Medical Center

Status

Completed

Conditions

Atherosclerosis

Treatments

Drug: statin treatment

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT03354156
NL50608.091.14

Details and patient eligibility

About

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.

Full description

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

45 participants in 2 patient groups

High-LDL
Description:
patients with LDL cholesterol levels of \>4.9 mmo/l, who have not been treated with statins in the past years, and who have an indication for treatment with statins.
Treatment:
Drug: statin treatment
Control
Description:
control subjects with an LDL cholesterol level of \<3.5 mmol/l

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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