Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 10:34 PM
Study NCT ID:
NCT01176357
Status:
UNKNOWN
Last Update Posted:
2010-08-06
First Post:
2009-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adiponectin and Inflammatory Mediators in Mediastinal Adipose Tissues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Adipose tissue biopsy samples from mediastinal fat, epicardial fat, subcutaneous fat in thoracic region or abdominal region and subcutaneous fat in leg were obtained soon after sternotomy or thoracotomy before the initiation of cardiopulmonary bypass.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'lastUpdateSubmitDate': '2010-08-04', 'studyFirstSubmitDate': '2009-02-06', 'studyFirstSubmitQcDate': '2010-08-04', 'lastUpdatePostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary artery disease (CAD)', 'atherosclerosis', 'mediastinal adipose tissue', 'adiponectin, inflammatory mediators'], 'conditions': ['Coronary Artery Disease', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'Coronary artery disease (CAD), the most common type of heart disease, is caused by hardening of the arteries, or atherosclerosis that is an inflammatory process in which immune mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions in the arterial trees. Epidemiological studies have found that increased cardiovascular risks are associated with increased levels of inflammatory cytokines (eg, interleukin-6 \\[IL-6\\] and tumor necrosis factor-alpha\\[TNF-alpha\\]) or their hepatic product, C-reactive protein (CRP). Higher expression of interleukin-Ibeta(IL-1beta),IL-6, monocyte chemotactic protein-1 (MCP-1), and TNF-alpha were observed in epicardial adipose tissues in patients with CAD. These findings suggested that the pericoronary tissues could be a source of inflammatory mediators or act as paracrine that lead to vascular inflammation on CAD pathogenesis. However, adiponectin, a kind of adipocytokine, produced and secreted exclusively by adipose tissue, has been reported to have a variety of anti-inflammatory functions against atherosclerosis, resulting in risk reduction for incidence of CAD events. It remains unclear whether adiponectin and inflammatory mediators in mediastinal adipose tissue contribute to CAD. We therefore aim to analyze the expression of adiponectin and inflammatory mediators in mediastinal adipose tissue between patients with CAD and with valve diseases, and to correlate these parameters with clinical atherosclerotic risks, medications (statins or antiplatelet), and blood sugar.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CAD or with valve diseases proposed to have cardiac operations', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient underwent CABG or valve surgery in our hospital will be included\n\nExclusion Criteria:\n\n* liver disease\n* dhronic renal insufficiency\n* neoplastic diseases\n* taking steroids\n* congestive heart failure'}, 'identificationModule': {'nctId': 'NCT01176357', 'briefTitle': 'Adiponectin and Inflammatory Mediators in Mediastinal Adipose Tissues', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Adiponectin and Inflammatory Mediators in Mediastinal Adipose Tissues Between Patients With Coronary Artery Diseases and With Valvular Diseases', 'orgStudyIdInfo': {'id': '96039'}, 'secondaryIdInfos': [{'id': 'FEMH-96-D-003'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'CABG'}, {'label': '2', 'description': 'Valve surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuan-Ming Chiu, MD, PhD', 'role': 'CONTACT', 'phone': '886-2-89667000'}], 'facility': 'FEMH', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Kuan-Ming Chiu, MD, PhD', 'role': 'CONTACT', 'phone': '886-2-89667000'}], 'overallOfficials': [{'name': 'Kuan-Ming Chiu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FEMH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Shih-Hong Huang', 'oldOrganization': 'Far Eastern Memorial Hospital'}}}}