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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02519257
Other study ID # FEMH-96091
Secondary ID
Status Completed
Phase N/A
First received August 2, 2015
Last updated August 6, 2015
Start date August 2008
Est. completion date July 2010

Study information

Verified date August 2015
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- coronary artery bypass grafting surgery

- valvular surgery

Exclusion Criteria:

- liver disease (GPT 2 times greater than normal limits)

- chronic renal insufficiency (Creatinine > 2.0 mg/dL)

- neoplastic diseases

- taking steroids

- congestive heart failure

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Procedure:
CAD
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.
VHD
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.

Locations

Country Name City State
Taiwan Far Eastern Memorial Hospital New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (25)

Fernández-Real JM, López-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. — View 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. Epub 2005 May 5. — View 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. — View 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. — View 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. — View Citation

Lindahl B, Toss H, Siegbahn A, Venge P, Wallentin L. Markers of myocardial damage and inflammation in relation to long-term mortality in unstable coronary artery disease. FRISC Study Group. Fragmin during Instability in Coronary Artery Disease. N Engl J Med. 2000 Oct 19;343(16):1139-47. — View 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. Epub 2002 Jul 22. — View Citation

Matsuzawa Y. Adipocytokines and metabolic syndrome. Semin Vasc Med. 2005 Feb;5(1):34-9. Review. — View Citation

Mazurek T, Zhang L, Zalewski A, Mannion JD, Diehl JT, Arafat H, Sarov-Blat L, O'Brien S, Keiper EA, Johnson AG, Martin J, Goldstein BJ, Shi Y. Human epicardial adipose tissue is a source of inflammatory mediators. Circulation. 2003 Nov 18;108(20):2460-6. Epub 2003 Oct 27. — View Citation

Miyata K, Shimokawa H, Kandabashi T, Higo T, Morishige K, Eto Y, Egashira K, Kaibuchi K, Takeshita A. Rho-kinase is involved in macrophage-mediated formation of coronary vascular lesions in pigs in vivo. Arterioscler Thromb Vasc Biol. 2000 Nov;20(11):2351-8. — View 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. — View 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. — View 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. — View Citation

Ouchi N, Kihara S, Arita Y, Maeda K, Kuriyama H, Okamoto Y, Hotta K, Nishida M, Takahashi M, Nakamura T, Yamashita S, Funahashi T, Matsuzawa Y. Novel modulator for endothelial adhesion molecules: adipocyte-derived plasma protein adiponectin. Circulation. 1999 Dec 21-28;100(25):2473-6. — View 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. — View Citation

Prescott MF, McBride CK, Court M. Development of intimal lesions after leukocyte migration into the vascular wall. Am J Pathol. 1989 Nov;135(5):835-46. — View Citation

Ridker PM, Rifai N, Pfeffer M, Sacks F, Lepage S, Braunwald E. Elevation of tumor necrosis factor-alpha and increased risk of recurrent coronary events after myocardial infarction. Circulation. 2000 May 9;101(18):2149-53. — View Citation

Ridker PM, Rifai N, Stampfer MJ, Hennekens CH. Plasma concentration of interleukin-6 and the risk of future myocardial infarction among apparently healthy men. Circulation. 2000 Apr 18;101(15):1767-72. — View 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. — View Citation

Shimada K, Miyazaki T, Daida H. Adiponectin and atherosclerotic disease. Clin Chim Acta. 2004 Jun;344(1-2):1-12. Review. — View Citation

Shimokawa H, Ito A, Fukumoto Y, Kadokami T, Nakaike R, Sakata M, Takayanagi T, Egashira K, Takeshita A. Chronic treatment with interleukin-1 beta induces coronary intimal lesions and vasospastic responses in pigs in vivo. The role of platelet-derived growth factor. J Clin Invest. 1996 Feb 1;97(3):769-76. — View Citation

Staiger H, Tschritter O, Machann J, Thamer C, Fritsche A, Maerker E, Schick F, Häring HU, Stumvoll M. Relationship of serum adiponectin and leptin concentrations with body fat distribution in humans. Obes Res. 2003 Mar;11(3):368-72. — View 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. Epub 2002 Nov 12. — View 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. — View 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. — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary CD91 (Thy-1) up to 24 months No
Secondary CD45 up to 24 months Yes
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