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临床试验/NCT01414621
NCT01414621已完成不适用

IRB #14547: Expression of Angiogenic Factors in Myocardial Tissue in Diabetic and Non-diabetic Patients Undergoing Coronary Bypass Surgery

University of Virginia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
tissue levels of HIF-1, VEGF and angiostatin

研究概览

简要总结

The purpose of this study is to evaluate whether angiogenesis is decreased in diabetic patients with coronary artery disease compared to non-diabetics with coronary artery disease. The protein expression of angiogenic factors will be examined in atrial tissue prior to initiation of cardiopulmonary bypass in patients undergoing coronary bypass surgery.

The goal of this project is to evaluate the tissue levels of HIF-1, VEGF and angiostatin in diabetic and non-diabetic patients coming for on-pump coronary artery bypass graft (CABG).

详细描述

Coronary artery disease and its complications are the leading cause of death in the western world. Diabetes mellitus (DM) is one of the major risk factors to develop coronary artery disease, myocardial infarction and post-infarction complication1-3. Furthermore, mortality from myocardial infarction is almost doubled in diabetic patients compared to non-diabetics4. Despite significant amount of research, the basis for these differences in outcome still remains unclear. The survival of myocardial tissue subjected to ischemia can be increased by the ability to promote growth of new blood vessels into ischemic areas, thus limiting regions of impairment and ultimately preserving myocardial function. Hypoxia inducible factor (HIF) -1 is a transcription factor that promotes the expression of several genes that confer protection against hypoxia/ischemia through angiogenesis, erythropoiesis, vasodilation, and altered glucose metabolism5,6. Our hypothesis is that angiogenesis may be impaired in diabetes mainly via decreased protein expression and activation of HIF-1 and its main downstream target vascular endothelial growth factor (VEGF), as well as the inhibitor angiogenesis factor, angiostatin7, in the heart. Therefore the purpose of this study is to examine whether the angiogenic process during coronary ischemia is influenced by diabetes. To address these questions, HIF-1, VEGF and angiostatin protein expression will be evaluated in atrial tissue obtained from patients with and without diabetes who will undergo coronary bypass surgery. In addition comparison between emergency and elective procedure will be performed in regard to HIF-1 and VEGF protein levels and correlation with chronic statin therapy will be performed.

During the cannulation process, prior to initiation of cardiopulmonary bypass (CPB) during heart surgery, a small piece of the right atrium is cut in order to insert a venous cannula into that chamber. The investigators intend to use this piece of tissue (that is routinely wasted) in our protein and histological analyses.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • on-pump CABG
  • 18 years of age & older
  • informed consent

排除标准

  • active malignancy
  • severe lung disease (requiring home O2 therapy)
  • severe anemia<8g/dl
  • patient with moderate or severe renal dysfunction
  • off- pump CABG

结局指标

主要结局

tissue levels of HIF-1, VEGF and angiostatin

时间窗: initiation of CPB/ day 1

The investigators will evaluate tissue levels of HIF-1, VEGF and angiostatin in diabetic and non-diabetic patients coming for on-pump CABG.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Raphael

Attending Anesthesiologist

University of Virginia

研究点 (1)

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