Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-03-20 @ 6:03 PM
Study NCT ID:
NCT00114504
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2005-06-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'naikai@med.kurume-u.ac.jp', 'phone': '+81-942-31-7562', 'title': 'Hisashi Kai', 'organization': 'Kurume University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Simvastatin Group', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plaque Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin Group', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone or 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '1.59', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in plaque inflammation was assessed by changes in the plaque SUV.', 'unitOfMeasure': 'SUV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Circulating Inflammation Marker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin Group Baseline', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy at baseline'}, {'id': 'OG001', 'title': 'Simvastatin Group at 3 Month', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months'}, {'id': 'OG002', 'title': 'Control Group Baseline', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone at baseline'}, {'id': 'OG003', 'title': 'Control Group at 3 Months', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '0.07', 'spread': '0.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in circulating hsCRP levels', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simvastatin Group', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Simvastatin Group', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '9', 'groupId': 'BG000'}, {'value': '62', 'spread': '6', 'groupId': 'BG001'}, {'value': '63', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'No Japanese', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2005-06-15', 'resultsFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2005-06-15', 'lastUpdatePostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-13', 'studyFirstPostDateStruct': {'date': '2005-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque Inflammation', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in plaque inflammation was assessed by changes in the plaque SUV.'}], 'secondaryOutcomes': [{'measure': 'Circulating Inflammation Marker', 'timeFrame': 'Baseline, 3 months', 'description': 'Change in circulating hsCRP levels'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atherosclerosis', 'inflammation', 'statins', 'PET', 'carotid ultrasonography'], 'conditions': ['Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '17418291', 'type': 'DERIVED', 'citation': 'Tahara N, Kai H, Yamagishi S, Mizoguchi M, Nakaura H, Ishibashi M, Kaida H, Baba K, Hayabuchi N, Imaizumi T. Vascular inflammation evaluated by [18F]-fluorodeoxyglucose positron emission tomography is associated with the metabolic syndrome. J Am Coll Cardiol. 2007 Apr 10;49(14):1533-9. doi: 10.1016/j.jacc.2006.11.046. Epub 2007 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether FDG-PET is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation. The usefulness of FDG-PET in risk stratification is also investigated.', 'detailedDescription': 'There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. However, currently, no non-invasive method is available for detecting plaque inflammation in clinical practice. FDG-PET can visualize activated metabolic levels of not only tumor cells but also inflammatory cells. Thus, it is possible that FDG-PET can detect atherosclerotic plaque inflammation and that, if so, FDG-PET can monitor the direct effect of statins on plaque inflammation. Additionally, monitoring the plaque inflammation by FDG-PET may be useful for determining the risk stratification of atherosclerotic patients.\n\nOriginally, we sought to compare patients with FDG-positive plaque with patients with plaque but not with FDG uptake, patients with FDG-positive plaque receiving statin therapy, and patients with FDG-positive plaque receiving diet management therapy. However, because patient number enrolled in the study was too small, the comparison was performed between FDG-positive patients with and without any statin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Protocol 1: patients who had carotid atherosclerosis detected by carotid ultrasound.\n* Protocol 2: patients who underwent FDG-PET for cancer screening and had vascular FDG uptakes\n\nExclusion Criteria:\n\n* Active inflammatory diseases\n* Dyslipidemia under medications\n* Uncontrolled diabetes mellitus, vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases\n* Known systemic disorders such as hepatic, renal, hematopoietic, and malignant diseases'}, 'identificationModule': {'nctId': 'NCT00114504', 'briefTitle': 'Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Kurume University'}, 'officialTitle': 'Detection of Atherosclerotic Plaque Inflammation and Visualization of Anti-inflammatory Effects of Statins on Plaque Inflammation by FDG-PET', 'orgStudyIdInfo': {'id': 'KurumeU-2416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simvastatin group', 'description': 'Patients with FDG-positive plaque who received simvastatin and diet therapy', 'interventionNames': ['Drug: simvastatin']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients FDG-positive plaque who received diet therapy alone'}], 'interventions': [{'name': 'simvastatin', 'type': 'DRUG', 'otherNames': ['control'], 'description': 'simvastatin 5-10 mg/day', 'armGroupLabels': ['Simvastatin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '830-0011', 'city': 'Kurume', 'country': 'Japan', 'facility': 'Kurume University Hospital', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}], 'overallOfficials': [{'name': 'Hisashi Kai, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Third Department of Internal Medicine, Kurume University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kurume University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hisashi Kai', 'investigatorAffiliation': 'Kurume University'}}}}