跳至主要内容
临床试验/NCT03090763
NCT03090763Unknown不适用

Role of Circulating MicroRNAs in Pathogenesis of Aneurysms of the Abdominal and Thoracic Aorta - Study "Micro AAA"

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Correlation between the level of the circulating miRNAs and the maximal diameter of the aneurysm sac.

研究概览

简要总结

The objective of this study is to establish whether patients with aortic aneurysm, compared to general population, have higher levels of selected miRNAs and whether there is significant association between the level of miRNA in circulating blood and the size of the aortic aneurysm or the risk of its rupture.

详细描述

Aneurysm of the abdominal and thoracic aorta represents a major cause of cardiovascular morbidity and mortality. The course of this condition can stay asymptomatic for long, and its first manifestation can be acute rupture of the aneurysm sac with life-threatening bleeding. Detection of patients at risk and their early treatment significantly reduce the percentage of this potentially lethal complications.

Aortic diseases are most often degenerative processes with a varying involvement of genetic predisposition. In literature, a substantial number of genes were proved to affect the metabolism of the vessel wall and to determine production of structural proteins, which were associated with the vascular pathologies. Pathophysiologic mechanisms of lesions of the aortic wall have not been completely understood. Among other, they include endothelial dysfunction, chronic inflammation of the vessel wall, apoptosis of smooth muscle cells and degradation of the extracellular matrix, resulting in the loss of integrity of layers of the vessel wall and decrease in its strength, which leads to dilation, rupture or dissection. Apart from mutations in genes coding the structural proteins of the vessel wall, many other potential biomarkers were proposed for early diagnosis of aortic aneurysm. These include microRNA (miRNA), one-fibre chains of non-coding ribonucleic acid which are several nucleotides long and are involved in the gene expression through the mechanism of inhibition of mRNA translation or increase in its degradation. Recently, association of levels of these miRNAs to presence and growth of aortic aneurysms has been described.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • study population:
  • signed informed consent for participation to the study;
  • age above 18 years;
  • presence of untreated thoracic or abdominal aortic aneurysm (TAA or AAA);
  • CT-verified diagnosis of AAA/TAA including measurement of the maximum diameter of the aneurysm.
  • control population:
  • signed informed consent for participation in the study;
  • age above 18 years;
  • absence of a thoracic or abdominal aortic aneurysm (TAA or AAA).

排除标准

  • life expectation above one year;
  • history of myocardial infarction or unstable angina pectoris 1 month ago.

结局指标

主要结局

Correlation between the level of the circulating miRNAs and the maximal diameter of the aneurysm sac.

时间窗: March 2017

Correlation between the level of the circulating miRNAs and the maximal diameter of the aneurysm sac.

Difference in levels of circulating miRNAs

时间窗: March 2017

Difference in levels of circulating miRNAs (in ng/μl) in the population of patients with AAA/TAA compared to the control population without the aortic disease.

次要结局

未报告次要终点

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ass. prof. Jean-Claude M. Lubanda, MD, Ph.D

Ass.prof.

Charles University, Czech Republic

研究点 (1)

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