Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-26 @ 11:15 AM
Study NCT ID:
NCT02519257
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2015-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship of Adiponectin in Adipose Tissue, Thy-1 in Plaques, and Inflammatory Mediators With Cardiac Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C568331', 'term': 'JCAD protein, mouse'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2015-08-02', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD91 (Thy-1)', 'timeFrame': 'up to 24 months'}], 'secondaryOutcomes': [{'measure': 'CD45', 'timeFrame': 'up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CAD', 'VHD', 'Thy-1'], 'conditions': ['Heart Surgery']}, 'referencesModule': {'references': [{'pmid': '11036119', 'type': 'BACKGROUND', 'citation': 'Lindahl B, Toss H, Siegbahn A, Venge P, Wallentin L. 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Circulation. 1999 Dec 21-28;100(25):2473-6. doi: 10.1161/01.cir.100.25.2473.'}, {'pmid': '12634431', 'type': 'BACKGROUND', 'citation': 'Staiger H, Tschritter O, Machann J, Thamer C, Fritsche A, Maerker E, Schick F, Haring HU, Stumvoll M. Relationship of serum adiponectin and leptin concentrations with body fat distribution in humans. Obes Res. 2003 Mar;11(3):368-72. doi: 10.1038/oby.2003.48.'}, {'pmid': '14564678', 'type': 'BACKGROUND', 'citation': 'Yatagai T, Nagasaka S, Taniguchi A, Fukushima M, Nakamura T, Kuroe A, Nakai Y, Ishibashi S. Hypoadiponectinemia is associated with visceral fat accumulation and insulin resistance in Japanese men with type 2 diabetes mellitus. Metabolism. 2003 Oct;52(10):1274-8. doi: 10.1016/s0026-0495(03)00195-1.'}, {'pmid': '15968578', 'type': 'BACKGROUND', 'citation': 'Matsuzawa Y. Adipocytokines and metabolic syndrome. Semin Vasc Med. 2005 Feb;5(1):34-9. doi: 10.1055/s-2005-871744.'}, {'pmid': '15877215', 'type': 'BACKGROUND', 'citation': 'Filippi E, Sentinelli F, Romeo S, Arca M, Berni A, Tiberti C, Verrienti A, Fanelli M, Fallarino M, Sorropago G, Baroni MG. The adiponectin gene SNP+276G>T associates with early-onset coronary artery disease and with lower levels of adiponectin in younger coronary artery disease patients (age <or=50 years). J Mol Med (Berl). 2005 Sep;83(9):711-9. doi: 10.1007/s00109-005-0667-z. Epub 2005 May 5.'}, {'pmid': '12843170', 'type': 'BACKGROUND', 'citation': 'Shimabukuro M, Higa N, Asahi T, Oshiro Y, Takasu N, Tagawa T, Ueda S, Shimomura I, Funahashi T, Matsuzawa Y. Hypoadiponectinemia is closely linked to endothelial dysfunction in man. J Clin Endocrinol Metab. 2003 Jul;88(7):3236-40. doi: 10.1210/jc.2002-021883.'}, {'pmid': '12788878', 'type': 'BACKGROUND', 'citation': 'Fernandez-Real JM, Lopez-Bermejo A, Casamitjana R, Ricart W. Novel interactions of adiponectin with the endocrine system and inflammatory parameters. J Clin Endocrinol Metab. 2003 Jun;88(6):2714-8. doi: 10.1210/jc.2002-021583.'}, {'pmid': '10961870', 'type': 'BACKGROUND', 'citation': 'Yokota T, Oritani K, Takahashi I, Ishikawa J, Matsuyama A, Ouchi N, Kihara S, Funahashi T, Tenner AJ, Tomiyama Y, Matsuzawa Y. Adiponectin, a new member of the family of soluble defense collagens, negatively regulates the growth of myelomonocytic progenitors and the functions of macrophages. Blood. 2000 Sep 1;96(5):1723-32.'}, {'pmid': '11222466', 'type': 'BACKGROUND', 'citation': 'Ouchi N, Kihara S, Arita Y, Nishida M, Matsuyama A, Okamoto Y, Ishigami M, Kuriyama H, Kishida K, Nishizawa H, Hotta K, Muraguchi M, Ohmoto Y, Yamashita S, Funahashi T, Matsuzawa Y. Adipocyte-derived plasma protein, adiponectin, suppresses lipid accumulation and class A scavenger receptor expression in human monocyte-derived macrophages. Circulation. 2001 Feb 27;103(8):1057-63. doi: 10.1161/01.cir.103.8.1057.'}, {'pmid': '12748229', 'type': 'BACKGROUND', 'citation': 'Miyazaki T, Shimada K, Mokuno H, Daida H. Adipocyte derived plasma protein, adiponectin, is associated with smoking status in patients with coronary artery disease. Heart. 2003 Jun;89(6):663. doi: 10.1136/heart.89.6.663. No abstract available.'}, {'pmid': '15149866', 'type': 'BACKGROUND', 'citation': 'Shimada K, Miyazaki T, Daida H. Adiponectin and atherosclerotic disease. Clin Chim Acta. 2004 Jun;344(1-2):1-12. doi: 10.1016/j.cccn.2004.02.020.'}, {'pmid': '12138120', 'type': 'BACKGROUND', 'citation': 'Matsuda M, Shimomura I, Sata M, Arita Y, Nishida M, Maeda N, Kumada M, Okamoto Y, Nagaretani H, Nishizawa H, Kishida K, Komuro R, Ouchi N, Kihara S, Nagai R, Funahashi T, Matsuzawa Y. Role of adiponectin in preventing vascular stenosis. The missing link of adipo-vascular axis. J Biol Chem. 2002 Oct 4;277(40):37487-91. doi: 10.1074/jbc.M206083200. Epub 2002 Jul 22.'}, {'pmid': '12451000', 'type': 'BACKGROUND', 'citation': 'Okamoto Y, Kihara S, Ouchi N, Nishida M, Arita Y, Kumada M, Ohashi K, Sakai N, Shimomura I, Kobayashi H, Terasaka N, Inaba T, Funahashi T, Matsuzawa Y. Adiponectin reduces atherosclerosis in apolipoprotein E-deficient mice. Circulation. 2002 Nov 26;106(22):2767-70. doi: 10.1161/01.cir.0000042707.50032.19.'}, {'pmid': '12431986', 'type': 'BACKGROUND', 'citation': 'Yamauchi T, Kamon J, Waki H, Imai Y, Shimozawa N, Hioki K, Uchida S, Ito Y, Takakuwa K, Matsui J, Takata M, Eto K, Terauchi Y, Komeda K, Tsunoda M, Murakami K, Ohnishi Y, Naitoh T, Yamamura K, Ueyama Y, Froguel P, Kimura S, Nagai R, Kadowaki T. Globular adiponectin protected ob/ob mice from diabetes and ApoE-deficient mice from atherosclerosis. J Biol Chem. 2003 Jan 24;278(4):2461-8. doi: 10.1074/jbc.M209033200. Epub 2002 Nov 12.'}, {'pmid': '12524229', 'type': 'BACKGROUND', 'citation': 'Kumada M, Kihara S, Sumitsuji S, Kawamoto T, Matsumoto S, Ouchi N, Arita Y, Okamoto Y, Shimomura I, Hiraoka H, Nakamura T, Funahashi T, Matsuzawa Y; Osaka CAD Study Group. Coronary artery disease. Association of hypoadiponectinemia with coronary artery disease in men. Arterioscler Thromb Vasc Biol. 2003 Jan 1;23(1):85-9. doi: 10.1161/01.atv.0000048856.22331.50.'}, {'pmid': '12748233', 'type': 'BACKGROUND', 'citation': 'Kojima S, Funahashi T, Sakamoto T, Miyamoto S, Soejima H, Hokamaki J, Kajiwara I, Sugiyama S, Yoshimura M, Fujimoto K, Miyao Y, Suefuji H, Kitagawa A, Ouchi N, Kihara S, Matsuzawa Y, Ogawa H. The variation of plasma concentrations of a novel, adipocyte derived protein, adiponectin, in patients with acute myocardial infarction. Heart. 2003 Jun;89(6):667. doi: 10.1136/heart.89.6.667. No abstract available.'}, {'pmid': '15084551', 'type': 'BACKGROUND', 'citation': 'Nakamura Y, Shimada K, Fukuda D, Shimada Y, Ehara S, Hirose M, Kataoka T, Kamimori K, Shimodozono S, Kobayashi Y, Yoshiyama M, Takeuchi K, Yoshikawa J. Implications of plasma concentrations of adiponectin in patients with coronary artery disease. Heart. 2004 May;90(5):528-33. doi: 10.1136/hrt.2003.011114.'}, {'pmid': '16321391', 'type': 'BACKGROUND', 'citation': 'Iwashima Y, Horio T, Suzuki Y, Kihara S, Rakugi H, Kangawa K, Funahashi T, Ogihara T, Kawano Y. Adiponectin and inflammatory markers in peripheral arterial occlusive disease. Atherosclerosis. 2006 Oct;188(2):384-90. doi: 10.1016/j.atherosclerosis.2005.10.039.'}]}, 'descriptionModule': {'briefSummary': "Atherosclerosis is an inflammatory process in which immune mechanisms interact with metabolic risk factors to initiate, propagate, and activate lesions in the arterial trees and is known as the main cause of coronary artery disease (CAD). Recently, there are more and more studies highlighted the potential importance of adipose tissue in relation to inflammation effects on CAD pathogenesis. However, it remains unclear whether Thy-1, adiponectin or any other inflammatory mediators in mediastinal adipose tissue contribute to CAD. In this study, we aim to analyze the expression of inflammatory mediators' expression via in vitro assay (3T3-L1 cell culture) and in vivo assay (human adipose tissues).", 'detailedDescription': "In addition, we'd like to investigate the association of the investigators' findings with clinical atherosclerotic risks, medications (statins or antiplatelet), and blood sugar. Now, we've established cell assay and successfully transformed mature adipocyte from 3T3-L1 cells. Besides, there were nighty-six patients enrolled into this study. Flow cytometry of Thy-1 and MCP-1 concentration in cultured medium by ELISA were also analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* coronary artery bypass grafting surgery\n* valvular surgery\n\nExclusion Criteria:\n\n* liver disease (GPT 2 times greater than normal limits)\n* chronic renal insufficiency (Creatinine \\> 2.0 mg/dL)\n* neoplastic diseases\n* taking steroids\n* congestive heart failure'}, 'identificationModule': {'nctId': 'NCT02519257', 'briefTitle': 'The Relationship of Adiponectin in Adipose Tissue, Thy-1 in Plaques, and Inflammatory Mediators With Cardiac Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'The Relationship of Adiponectin in Adipose Tissue, Thy-1 in Plaques, and Inflammatory', 'orgStudyIdInfo': {'id': 'FEMH-96091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAD', 'description': 'Patients with valve diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.', 'interventionNames': ['Procedure: CAD']}, {'type': 'EXPERIMENTAL', 'label': 'VHD', 'description': 'Patients with valve diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.', 'interventionNames': ['Procedure: VHD']}], 'interventions': [{'name': 'CAD', 'type': 'PROCEDURE', 'otherNames': ['coronary artery disease'], 'description': 'Patients with CAD diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.', 'armGroupLabels': ['CAD']}, {'name': 'VHD', 'type': 'PROCEDURE', 'otherNames': ['valve diseases'], 'description': 'Patients with valve diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.', 'armGroupLabels': ['VHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Shu-Hsun Chu', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}