Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-03-03 @ 8:08 AM
Study NCT ID:
NCT01671306
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2012-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-22', 'studyFirstSubmitDate': '2012-08-18', 'studyFirstSubmitQcDate': '2012-08-22', 'lastUpdatePostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary collaterals', 'diabetes mellitus', 'monocyte subsets'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral development in non-diabetic patients with stable coronary artery disease. Our aim in this study is to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development in type 2 diabetic patients.', 'detailedDescription': '83 diabetic patients with severe coronary artery disease were enrolled in the study. These patients were investigated according to their collateral development. Monocytes and their subtypes, namely CD14++CD16- and CD14+CD16+ cells were compared in 2 groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of 83 consecutive type 2 diabetic patients who have undergone coronary angiography because of stable symptoms and signs of coronary artery disease. The main inclusion criterion was the presence of \\>95% stenosis of at least one major coronary artery in their first coronary angiogram.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of \\> 95% stenosis of at least one major coronary artery in their first coronary angiogram.\n\nExclusion Criteria:\n\n* Patients experiencing acute coronary syndrome either with or without ST elevation in the last one month\n* Evidence of ongoing infection and inflammation, known malignancy and chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT01671306', 'briefTitle': 'The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Samsun Education and Research Hospital'}, 'officialTitle': 'The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus', 'orgStudyIdInfo': {'id': '1037'}, 'secondaryIdInfos': [{'id': 'Samsun EAH', 'type': 'OTHER', 'domain': 'Samsun EAH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Collateral, coronary disease', 'description': 'Patients are grouped into 2: Good and poor collateral development'}, {'label': 'collateral', 'description': 'Patients are grouped into 2: Good and poor collateral development'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Uğur ARSLAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsun Education and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsun Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist of Cardiology', 'investigatorFullName': 'Ugur ARSLAN', 'investigatorAffiliation': 'Samsun Education and Research Hospital'}}}}