Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT00949169
Status:
COMPLETED
Last Update Posted:
2009-07-30
First Post:
2009-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Carotid Intima-media Thickness (IMT) and Large-vessel Atherosclerosis by Multidetector Computed Tomography (MDCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-29', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT.', 'timeFrame': '17 months'}], 'secondaryOutcomes': [{'measure': 'We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.', 'timeFrame': '17 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atherosclerosis', 'Carotid IMT', 'Multidetector CT', 'Type 2 diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate whether carotid IMT can predict the presence of more advanced atherosclerosis such as carotid stenosis, coronary or intracranial artery disease by MDCT and whether MDCT could be useful next step for more aggressive treatment modality in Korean type 2 diabetic patients.', 'detailedDescription': 'We evaluated mean/maximal carotid IMT in seventy-one type 2 diabetic subjects, and defined increased carotid IMT as maximal IMT ≥ 1.0 mm. Multidetector CT (MDCT) and pulse wave velocity (PWV) were taken to evaluate carotid artery stenosis (CS), coronary artery disease (CAD), intracranial arterial lesion (ICA), and peripheral artery disease (PAD). We compared prevalence of large artery stenosis according to carotid IMT group and evaluated whether maximal IMT ≥ 1.0 mm could predict for significant CAD by MDCT. We performed invasive coronary angiography in some patients (N=14) and analyzed association for degrees of CAD between two angiographic methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'type 2 diabetic patients who had multiple cardiovascular risk factors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic patients who had multiple cardiovascular risk factors were recruited.\n* Patients who had atypical chest pain, EKG abnormality (ischemic ST-T changes or abnormal Q-wave), or history of previous cardiovascular disease were also included.\n\nExclusion Criteria:\n\n* Acute coronary SD, serum Cr\\>1.4 mg/dL, history of allergy to iodinated contrast dye were excluded.'}, 'identificationModule': {'nctId': 'NCT00949169', 'briefTitle': 'Carotid Intima-media Thickness (IMT) and Large-vessel Atherosclerosis by Multidetector Computed Tomography (MDCT)', 'organization': {'class': 'OTHER', 'fullName': 'Eulji University Hospital'}, 'officialTitle': 'Association of Carotid IMT and Large-vessel Atherosclerosis by MDCT in Korean Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'Eulji07-34'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carrotid IMT group according to maximal IMT', 'description': 'We defined increased IMT group as whom had maximal IMT ≥ 1.0 mm.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '139-711', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung Wan Min, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Eulji University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eulji University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Internal Medicine, Eulji University Hospital'}}}}