The Effect of Statin Treatment on Trained Innate Immunity

NCT03354156 | Completed

• 1 other identifier: NL50608.091.14
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Cytokine production capacity

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

  baseline

Secondary Outcomes (3)

• Cytokine production capacity

  Three months after start of statin treatment

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

  baseline

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

  Three months after start of statin treatment

Study Arms (2)

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.

Drug: statin treatment

Control

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

Interventions

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)

High-LDL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the outpatient clinics of the Radboudumc, AMC, or Erasmus MC, with LDL cholesterol levels \>4.9 mmol/l, who will treated with statins according to current guidelines, will be will be selected.

You may qualify if:

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

You may not qualify if:

• previous cardiovascular events.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• AIDS Malignancy Consortium: collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

Radboud university medical center

Nijmegen, 6500 GA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* plasma * chromatin and RNA from monocytes

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: November 27, 2017
• Study Start: January 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 27, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)