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临床试验/NCT02746822
NCT02746822已完成不适用

Thrombus Aspiration in Acute ST-elevation Myocardial Infarction

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Cell composition of the intracoronary thrombus related to symptom length

研究概览

简要总结

Thirty patients with acute ST-elevation myocardial infarction treated with primary PCI and aspiration of thrombus material from the infarct related coronary artery will be included. Both cellular and non cellular content of the thrombus will be examined with morphological and immunohistochemical methods and related to time from onset of symptoms to PCI, as well as to the degree of myocardial necrosis. Furthermore, mRNA expression of selected signal molecules will be performed. In addition, peripheral venous blood samples will be drawn and analyzed for signalling molecules and corresponding mRNA expression in circulating leukocytes.

详细描述

Observational, cross-sectional study on 30 patients with STEMI treated with thrombectomy and PCI with stent implantation. Composition and characteristics of the coronary thrombi with respect to cell types, genetic expression and presence of specific markers of inflammation, platelet activity, endothelial activation, coagulation and fibrinolysis will be investigated in relation to the levels of these markers in the general circulation, and specifically related to the time axis from symptom to PCI, as well as to the degree of myocardial necrosis.

Intracoronary thrombus will be retrieved by standard aspiration catheter, washed with saline and stored on formalin as advised by the Department of pathology, OUS Ullevål. A specific protocol for morphological and immunohistochemical methods is prepared and has been shown suitable in a pilot study on 5 patients. Assessment of coronary TIMI flow and peripheral blush grade after thrombus aspiration and PCI will be done. At the same time, peripheral venous blood will be drawn, processed and stored at -80˚C for later analyses. Demographic variables will be recorded.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both gender
  • age 18-75 years
  • typical symptoms of acute myocardial infarction
  • ST-elevation or presumed new left bundle branch block in the ECG
  • treated with aspiration of thrombus and primary PCI in the infarct related coronary artery

排除标准

  • Signs of infection
  • pulmonary embolism
  • chronic obstructive pulmonary disease
  • arrhythmias, abnormal renal and/or liver function
  • autoimmune disease
  • malignant disease

结局指标

主要结局

Cell composition of the intracoronary thrombus related to symptom length

时间窗: 24 hours

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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