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The Effect of Statin Treatment on Trained Innate Immunity

NCT ID: NCT03354156

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atherosclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

statin treatment

Intervention Type 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)

Control

control subjects with an LDL cholesterol level of \<3.5 mmol/l

No interventions assigned to this group

Interventions

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statin treatment

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AIDS Malignancy Consortium

NETWORK

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radboud university medical center

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL50608.091.14

Identifier Type: -

Identifier Source: org_study_id