跳至主要内容
临床试验/NCT02760914
NCT02760914进行中(未招募)不适用

Inflammatory Activity in Various Compartments of Adipose Tissue in Patients With Coronary Heart Disease

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
1
主要终点
Inflammasome-related proteins

研究概览

简要总结

The aims of the present project are to study possible differences in inflammatory gene expression and protein secretion in various compartments of adipose tissue being exposed during open cardiac surgery in patients with coronary heart disease undergoing coronary artery bypass surgery.

详细描述

The present study is observational with biochemical end-points to disclose inflammatory mechanisms in various compartments of adipose tissue in patients with coronary heart disease (CHD) compared to patients without significant CHD. Fifty patients with CHD undergoing coronary artery bypass surgery with open chest procedure will be included and 20 patients with valve disease without overt CHD undergoing open valve surgery will serve as a control group. No specific restrictions to inclusion other than lack of consent to participate after written and oral information are listed. In patients undergoing open heart surgery for CHD, representative peri-operative biopsies from epicardial, pericardial and subcutaneous fat will be gathered, carefully processed and deep-frozen to 80 degrees of frost for later analyses on histological/cellular components and on messenger ribonucleic acid for selected inflammatory variables. Simultaneously, blood samples (arterial blood at start of operation) will be collected, processed and deep-frozen at 80 degrees of frost for later analyses of relevant circulating inflammatory variables to correlation analyses with tissue samples, possibly also PaxGene tubes for messenger ribonucleic acid in circulating leukocytes.

The study will be conducted according to the Declaration of Helsinki, and in accordance with approval from the Regional Ethics Committee.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with coronary heart disease undergoing coronary artery bypass surgery

排除标准

  • 未提供

结局指标

主要结局

Inflammasome-related proteins

时间窗: At inclusion

Inflammasome-related proteins (IL-18, IL-1b, NLRP3, Caspase, TLR4, IL-6, IL-6R, gp130), markers of remodeling (i.e. MMP-9, TIMP-1, PAI-1, Galectin, EMMPRIN), adipokines (i.e adiponectin, visfatin), other relevant pro-and anti-inflammatory cytokines (like TNF-alpha, IL-8, IL-12, IFN-gamma, MCP-1, IL-4, IL-10, TGF beta.) Relevant laboratory methods; qPCR (mRNA - all compartments + PAXGenetubes (leukocytes); Immunohistochemically; Circulating (where possible) (ELISAs and/or Multiplex). Results will be recorded in a database for further statistical analyses.

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Svein Solheim

MD, PhD

Oslo University Hospital

研究点 (1)

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