Effect of Statins on Trained Immunity
Effect of Statins on Epigenetic Reprogramming of Monocytes in Patients With Elevated Levels of LDL
1 other identifier
observational
45
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedNovember 29, 2023
June 1, 2023
1.5 years
June 15, 2016
November 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in histone methylation levels in circulating monocytes
Histone methylation levels on different lysines of histone 3 will be analyzed at baseline and after 3 months of statin treatment
Baseline-3 months follow up
Secondary Outcomes (1)
Inflammatory phenotype
Baseline-3 months follow up
Study Arms (2)
Patients
Patients referred to the out-patient clinic with LDL levels \>4.9 mmol/l
Controls
Matched normocholesterolemic control subjects
Interventions
Eligibility Criteria
Subjects aged \>18 years who have been referred to the out-patient clinic and have LDL levels that require lipid lowering treatment (LDL\>4.9 mmol/l)
You may qualify if:
- Patients:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB, Netherlands
Academic Medical Center
Amsterdam, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 29, 2016
Study Start
June 1, 2015
Primary Completion
December 1, 2016
Study Completion
June 1, 2017
Last Updated
November 29, 2023
Record last verified: 2023-06