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Effect of Statins on Trained Immunity

NCT ID: NCT02817230

Last Updated: 2023-11-29

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

2015-06-30

Study Completion Date

2017-06-01

Brief Summary

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In this study, the investigators will determine whether patients with elevated levels of LDL are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to control subjects with healthy levels of LDL and whether regular statin treatment influences these changes.

Detailed Description

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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. Here the investigators hypothesize that monocytes of patients with elevated LDL cholesterol levels show epigenetic changes compared to normocholesterolemic subjects and that this can be reversed by treatment with statins.

Objective: The main objective is to study whether patients with elevated levels of LDL show increased Histone 3 Lysine 4 trimethylation in the promoter regions of pro-inflammatory cytokines and have an augmented ex vivo Toll-Like Receptor agonist-induced cytokine production in isolated monocytes compared to controls. Subsequently the investigators will study the effect of treatment with statins on these responses.

Study design: Observational study Study population: Subjects aged \>18 years who have been referred to the out-patient clinic and have LDL levels that require lipid lowering treatment and matched normocholesterolemic control subjects.

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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Patients

Patients referred to the out-patient clinic with LDL levels \>4.9 mmol/l

Statin

Intervention Type DRUG

Controls

Matched normocholesterolemic control subjects

No interventions assigned to this group

Interventions

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Statin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients:

* 18 years or older
* Elevated LDL levels (\>4.9 mmol/l)
* No previous cardiovascular events

Controls:

* Age \> 18 years
* LDL cholesterol \< 3.5 mmol/l
* No previous cardiovascular events

Exclusion Criteria

* Current lipid lowering treatment
* Known malignant disorders, auto-immune disorder, or diabetes
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
* Clinical signs of acute infection
* Use of anti-inflammatory medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

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 Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2014-1340

Identifier Type: -

Identifier Source: org_study_id