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The Relationship of Adiponectin in Adipose Tissue, Thy-1 in Plaques, and Inflammatory Mediators With Cardiac Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519257
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
Shu-Hsun Chu, Far Eastern Memorial Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Heart Surgery Procedure: CAD Procedure: VHD Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Relationship of Adiponectin in Adipose Tissue, Thy-1 in Plaques, and Inflammatory
Study Start Date : August 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: CAD
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.
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.
Other Name: coronary artery disease

Experimental: 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.
Procedure: 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.
Other Name: valve diseases




Primary Outcome Measures :
  1. CD91 (Thy-1) [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. CD45 [ Time Frame: up to 24 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519257


Locations
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Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan, 220
Sponsors and Collaborators
Far Eastern Memorial Hospital
Publications:

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Responsible Party: Shu-Hsun Chu, President, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02519257    
Other Study ID Numbers: FEMH-96091
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015
Keywords provided by Shu-Hsun Chu, Far Eastern Memorial Hospital:
CAD
VHD
Thy-1