Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-09 @ 11:08 AM
Study NCT ID:
NCT03354156
Status:
COMPLETED
Last Update Posted:
2017-11-27
First Post:
2016-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Statin Treatment on Trained Innate Immunity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* plasma\n* chromatin and RNA from monocytes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-23', 'studyFirstSubmitDate': '2016-04-21', 'studyFirstSubmitQcDate': '2017-11-23', 'lastUpdatePostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokine production capacity', 'timeFrame': 'baseline', 'description': "Cytokine production capacity of PBMC's at baseline in patients with elevated and normal cholesterol levels"}], 'secondaryOutcomes': [{'measure': 'Cytokine production capacity', 'timeFrame': 'Three months after start of statin treatment', 'description': "Cytokine production capacity of PBMC's at baseline in patients with elevated and normal cholesterol levels"}, {'measure': 'Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.', 'timeFrame': 'baseline', 'description': 'Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.'}, {'measure': 'Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.', 'timeFrame': 'Three months after start of statin treatment', 'description': 'Epigenetic modifications in the promoter regions of the pro-inflammatory cytokines in monocytes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerosis']}, 'descriptionModule': {'briefSummary': "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).\n\nIn 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.", 'detailedDescription': "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).\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Elevated LDL levels (\\>4.9 mmol/l)\n* Decision made by treating physician to initiate statin treatment\n\nExclusion Criteria:\n\n* previous cardiovascular events.'}, 'identificationModule': {'nctId': 'NCT03354156', 'acronym': 'SIMPEL', 'briefTitle': 'The Effect of Statin Treatment on Trained Innate Immunity', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Effect of Statins on Epigenetic Reprogramming of Monocytes in Patients With Elevated Levels of LDL', 'orgStudyIdInfo': {'id': 'NL50608.091.14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High-LDL', 'description': '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.', 'interventionNames': ['Drug: statin treatment']}, {'label': 'Control', 'description': 'control subjects with an LDL cholesterol level of \\<3.5 mmol/l'}], 'interventions': [{'name': 'statin treatment', 'type': 'DRUG', 'description': 'The patients with elevated LDL receive statin treatment in the context of normal patient care (so this is NOT an intervention of the study)', 'armGroupLabels': ['High-LDL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 GA', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud university medical center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'AIDS Malignancy Consortium', 'class': 'NETWORK'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}