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临床试验/NCT03354156
NCT03354156已完成不适用

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

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Cytokine production capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • previous cardiovascular events.

研究组 & 干预措施

High-LDL

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.

干预措施: statin treatment (Drug)

结局指标

主要结局

Cytokine production capacity

时间窗: baseline

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

次要结局

  • Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.(Three months after start of statin treatment)
  • Cytokine production capacity(Three months after start of statin treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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