Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-04 @ 6:33 PM
Study NCT ID:
NCT03322332
Status:
UNKNOWN
Last Update Posted:
2017-10-26
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-01-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-23', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between coronary artery disease and epicardial adipokines', 'timeFrame': 'Baseline measurement', 'description': 'Comparison of the mRNA and protein production of four adipokines \\[adiponectin, omentin-1, resistin, retinol binding protein-4(RBP4)\\] from the epicardial adipose tissue between the territories that are supplied by LAD and RCA. This comparison will be performed in the following clusters of groups:\n\n1. Cluster 1: NonDM-0 and DM-0 (comparison between territories that are supplied by non-stenosed coronary arteries)\n2. Cluster 2: NonDM-LR and DM-LR (comparison between territories that are supplied by stenosed coronary arteries)\n3. Cluster 3: NonDM-L, NonDM-R, DM-L and DM-R (comparison between a territory that is supplied by stenosed coronary artery and another territory that is supplied by non-stenosed coronary artery)'}], 'secondaryOutcomes': [{'measure': 'Impact of diabetes on epicardial adipokines', 'timeFrame': 'Baseline measurement', 'description': 'Comparison of the mRNA and protein production of four adipokines (adiponectin, omentin-1, resistin, RBP4) from the epicardial adipose tissue of the territory that is supplied by LAD or RCA between the following groups:\n\n1. NonDM-0 vs DM-0\n2. NonDM-L vs DM-L\n3. NonDM-R vs DM-R\n4. NonDM-LR vs DM-LR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adiponectin', 'omentin-1', 'resistin', 'RBP4', 'epicardial fat', 'Coronary artery disease'], 'conditions': ['Coronary Atherosclerosis', 'Adipokines']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate whether the expression and production of adipokines secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis.', 'detailedDescription': 'The aim of the study is to investigate whether the expression and production of four adipokines \\[adiponectin, omenin-1, resistin and retinol binding protein-4 (RBP4)\\] secreted by the epicardial adipose tissue correlate with the degree of coronary atherosclerosis. Specifically, this study aims to investigate whether the expression and production of these adipokines is different between two sites of the heart, that are perfused by coronary arteries with different degrees of stenosis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals undergoing cardiac surgery will be recruited in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Individuals undergoing cardiac surgery\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* HbA1c \\> 7.0%\n* Any change of antidiabetic medication the previous 3 months before the surgery\n* GFR \\< 60 mL/min/1.73 m2\n* Liver disease\n* Cancer\n* Non-treated hyperthyroidism or hypothyroidism\n* Autoimmune disease\n* Infection\n* Any change in body weight at least 5% the previous 3 months before surgery\n* Significant dehydration.\n* Taking any of the following drugs the previous 3 months before surgery: hormones, antiobesity drugs'}, 'identificationModule': {'nctId': 'NCT03322332', 'briefTitle': 'Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ioannina'}, 'officialTitle': 'The Role of Adipokines Secreted by Epicardial Adipose Tissue in the Atherosclerosis of Coronary Arteries', 'orgStudyIdInfo': {'id': '741'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NonDM-0', 'description': 'Nondiabetics without significant stenoses (\\> 50%) in the coronary arteries'}, {'label': 'NonDM-L', 'description': 'Nondiabetics with significant stenosis in the left anterior descending (LAD) coronary artery or in the Left main (LM) coronary artery, but without significant stenosis in the right coronary artery (RCA)'}, {'label': 'NonDM-R', 'description': 'Nondiabetics without significant stenosis in the LAD and in the LM, but with significant stenosis in the RCA'}, {'label': 'NonDM-LR', 'description': 'Nondiabetics with significant stenosis in the LAD or in the LM and with significant stenosis in the RCA'}, {'label': 'DM-0', 'description': 'Patients with type 2 diabetes mellitus (T2DM) without significant stenoses in the coronary arteries'}, {'label': 'DM-L', 'description': 'T2DM patients with significant stenosis in the LAD or in the LM, but without significant stenosis in RCA'}, {'label': 'DM-R', 'description': 'T2DM patients without significant stenosis in the LAD and in the LM, but with significant stenosis in the RCA'}, {'label': 'DM-LR', 'description': 'T2DM patients with significant stenosis in the LAD or in the LM and with significant stenosis in the RCA'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ioannina', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Vasiliki Kyrouli', 'role': 'CONTACT', 'phone': '0030 2651099519'}], 'facility': 'University Hospital of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}], 'centralContacts': [{'name': 'Eustratios Apostolakis, Professor', 'role': 'CONTACT', 'email': 'stratisapostolakis@yahoo.gr', 'phone': '0030 2651099679'}], 'overallOfficials': [{'name': 'Eustratios Apostolakis, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Ioannina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ioannina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist, Postdoctoral researcher', 'investigatorFullName': 'Georgios A. Christou', 'investigatorAffiliation': 'University Hospital, Ioannina'}}}}