Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT00795067
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2008-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis
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': 'platelet-poor plasma whole blood urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2008-11-20', 'lastUpdatePostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of circulating EMPs', 'timeFrame': 'at the time of carotid ultrasound examination'}], 'secondaryOutcomes': [{'measure': 'The occurrence of cerebrovascular and/or cardiovascular events', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that circulating endothelium-derived microparticle (EMP) may be a useful surrogate marker of atherosclerosis and future episode of cerebrovascular events. Peripheral blood is drawn at the time of carotid ultrasound examination. Circulating EMPs are counted using flow-cytometry. The correlation among circulating EMP, ultrasound findings, and atherosclerotic risk factors are determined by multiple stepwise regression analysis. The prevalence of cerebrovascular events is also determined during 3-year follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo carotid ultrasound examination for screening of atheroscrelosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who undergo carotid ultrasound examination for screening of atherosclerosis\n\nExclusion Criteria:\n\n* Cerebrovascular events within the last 12 months\n* Acute coronary syndrome, coronary and peripheral intervention within the last 6 months\n* Uncontrolled heart failure\n* Other severe systemic diseases'}, 'identificationModule': {'nctId': 'NCT00795067', 'briefTitle': 'Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Kurume University'}, 'officialTitle': 'Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis', 'orgStudyIdInfo': {'id': 'KurumeU-08060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carotid atherosclerosis group', 'description': 'Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening'}]}, 'contactsLocationsModule': {'locations': [{'zip': '830-0011', 'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kurume University Hospital', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}], 'overallOfficials': [{'name': 'Tsutomu Imaizumi, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kurume University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kurume University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of Medicine', 'investigatorFullName': 'Hisashi Kai', 'investigatorAffiliation': 'Kurume University'}}}}