AtherosclerosisSIMPELNCT03354156
The Effect of Statin Treatment on Trained Innate Immunity
An observational study of Atherosclerosis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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'. 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 treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2015to Dec 2016
- 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: 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.
Who may be able to join
- Aged 18 years or older
- Elevated LDL levels (>4.9 mmol/l)
- Decision made by treating physician to initiate statin treatment
Who cannot join
- previous cardiovascular events.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Statins on Epigenetic Reprogramming of Monocytes in Patients With Elevated Levels of LDL
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.
Read the detailed description
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
- Atherosclerosis
- Being tested
- statin treatment
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
statin treatmentDrug
The patients with elevated LDL receive statin treatment in the context of normal patient care (so this is NOT an intervention of the study)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: statin treatment | |
| Control | control subjects with an LDL cholesterol level of <3.5 mmol/l |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine production capacity
Cytokine production capacity of PBMC's at baseline in patients with elevated and normal cholesterol levels
Measured: baseline
Secondary outcomes (3)
Cytokine production capacity
Cytokine production capacity of PBMC's at baseline in patients with elevated and normal cholesterol levels
Measured: Three months after start of statin treatment
Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.
Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.
Measured: baseline
Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.
Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.
Measured: Three months after start of statin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study startJan 2015
- Primary completionNov 2016
- Study completionDec 2016
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.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- AIDS Malignancy Consortium, Erasmus Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354156
- Sponsor's protocol ID
- NL50608.091.14
- Acronym
- SIMPEL
- Status last verified
- Oct 2016
- First submitted
- 21 Apr 2016
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. 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
- NCT03354156
- Acronym / sponsor ID
- SIMPEL / NL50608.091.14
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- AIDS Malignancy Consortium, Erasmus Medical Center
- Study start
- Jan 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Nov 2017 (actual)
- 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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-LDL | – | Drug: statin treatmentpatients 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. |
| Control | – | –control subjects with an LDL cholesterol level of <3.5 mmol/l |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Elevated LDL levels (>4.9 mmol/l)
- Decision made by treating physician to initiate statin treatment
Key exclusion criteria (1 listed)
- previous cardiovascular events.
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 treatmentThe patients with elevated LDL receive statin treatment in the context of normal patient care (so this is NOT an intervention of the study) | Drug | High-LDL |
Primary outcome
Cytokine production capacity
Time frame: baseline
Cytokine production capacity of PBMC's at baseline in patients with elevated and normal cholesterol levels
3 secondary outcomes
Cytokine production capacity
Time frame: Three months after start of statin treatment
Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.
Time frame: baseline
Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.
Time frame: Three months after start of statin treatment
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 27 Nov 2017.
- Individual participant dataSharing planned: No
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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.
1 site 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 1 site 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 3 inclusion and 1 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 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Cytokine production capacity (time frame: baseline). 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 27 Nov 2017.