Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-01-01 @ 9:21 AM
Study NCT ID:
NCT00970918
Status:
COMPLETED
Last Update Posted:
2010-09-24
First Post:
2009-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Artery Conditions of 'At-risk' Asian People Not on Lipid-lowering Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Singapore']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002097', 'term': 'C-Reactive Protein'}], 'ancestors': [{'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000209', 'term': 'Acute-Phase Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D007162', 'term': 'Immunoproteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2609}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-22', 'studyFirstSubmitDate': '2009-08-25', 'studyFirstSubmitQcDate': '2009-09-02', 'lastUpdatePostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Carotid Intima Media Thickness of people with high risk of cardiovascular disease but not on lipid lowering drugs', 'timeFrame': 'IIMT measurements taken only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)'}], 'secondaryOutcomes': [{'measure': 'Lipid profile of people with high risk of cardiovascular disease but not on lipid lowering drugs', 'timeFrame': 'Blood sampling only once, either on Visit 1 or Visit 2 (time gap between V1 and V2 should be less than 3 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiovascular disease', 'Carotid Intima Media Thickness'], 'conditions': ['Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain the distribution of measurements of the intima media thickness of carotid arteries in people with high cardiovascular risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed informed consent.\n* Patients with at least two CVD risk factors but not on lipid-lowering agents\n\nExclusion Criteria:\n\n* Subjects with CHD, any conditions that may affect hs-CRP levels.\n* Subjects on any lipid-lowering drug treatment within the last 3 months prior study entry.'}, 'identificationModule': {'nctId': 'NCT00970918', 'acronym': 'CIMT', 'briefTitle': "Study of Artery Conditions of 'At-risk' Asian People Not on Lipid-lowering Drugs", 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Prevalence of Atherosclerotic Disease in Asian Subjects Not on Lipid-lowering Agents, But With at Least Two CVD Risk Factors', 'orgStudyIdInfo': {'id': 'D3560L00092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Procedure: Measurement of the Carotid Intima Media thickness', 'Biological: Blood sample testing for hs-CRP']}], 'interventions': [{'name': 'Measurement of the Carotid Intima Media thickness', 'type': 'PROCEDURE', 'description': 'one time, radiological procedure on both sides of the neck', 'armGroupLabels': ['1']}, {'name': 'Blood sample testing for hs-CRP', 'type': 'BIOLOGICAL', 'description': 'one time, blood sample taking', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Gurgaon', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 25.49781, 'lon': 82.15916}}, {'city': 'Jaipur', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Meerut', 'country': 'India', 'facility': 'Research Site', 'geoPoint': {'lat': 28.98002, 'lon': 77.70636}}, {'city': 'Denpasar', 'state': 'Bali', 'country': 'Indonesia', 'facility': 'Research Site', 'geoPoint': {'lat': -8.65, 'lon': 115.21667}}, {'city': 'Bandung-Jawa', 'state': 'Barat', 'country': 'Indonesia', 'facility': 'Research Site'}, {'city': 'Semarang-Jawa', 'state': 'Tengah', 'country': 'Indonesia', 'facility': 'Research Site'}, {'city': 'Surabaya', 'state': 'Timur', 'country': 'Indonesia', 'facility': 'Research Site', 'geoPoint': {'lat': -7.24917, 'lon': 112.75083}}, {'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Research Site', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'city': 'Manila', 'state': 'Manila', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': 'Research Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Kaohsiung', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Research Site'}, {'city': 'Shilin', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Research Site'}, {'city': 'Taoyuan', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Research Site'}, {'city': 'Patumwan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Research Site'}, {'city': 'Hanoi', 'state': 'Hanoi', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'city': 'Ho Chi Minh City', 'state': 'Ho Chi Min', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Guy Yeoman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asia Pacific Regional Office, AstraZeneca Singapore Pte Ltd 8 Wilkie Road, #07-01 Wilkie Edge, Singapore 228095'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca'}}}}