AtherosclerosisNCT02817230
Effect of Statins on Trained Immunity
An observational study of Atherosclerosis, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Statin
- How many people
- 45 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jun 2015to 1 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Academic Medical Center
Amsterdam
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
Erasmus Medical Center
Rotterdam
About this study
Official title: Effect of Statins on Epigenetic Reprogramming of Monocytes in Patients With Elevated Levels of LDL
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.
Read the detailed description
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
- Atherosclerosis
- Being tested
- Statin
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients referred to the out-patient clinic with LDL levels >4.9 mmol/l Receives: Drug: Statin | |
| Controls | Matched normocholesterolemic control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline-3 months follow up
Secondary outcomes (1)
Inflammatory phenotype
Measured: Baseline-3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817230
- Sponsor's protocol ID
- 2014-1340
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2016
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statins on Epigenetic Reprogramming of Monocytes in Patients With Elevated Levels of LDL
- ClinicalTrials.gov ID
- NCT02817230
- Acronym / sponsor ID
- 2014-1340
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: StatinPatients referred to the out-patient clinic with LDL levels >4.9 mmol/l |
| Controls | – | –Matched normocholesterolemic control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (8 listed)
- 18 years or older
- Elevated LDL levels (>4.9 mmol/l)
- No previous cardiovascular events
- Age > 18 years
- LDL cholesterol < 3.5 mmol/l
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin | Drug | Patients |
Primary outcome
Changes in histone methylation levels in circulating monocytes
Time frame: Baseline-3 months follow up
Histone methylation levels on different lysines of histone 3 will be analyzed at baseline and after 3 months of statin treatment
1 secondary outcome
Inflammatory phenotype
Time frame: Baseline-3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by Radboud University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in histone methylation levels in circulating monocytes (time frame: Baseline-3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.