Clinical trial NCT03090763: Role of Circulating MicroRNAs in Pathogenesis of Aneurysms of the Abdominal and Thoracic Aorta - Study "Micro AAA"
Official title: Role of Circulating MicroRNAs in Pathogenesis of Aneurysms of the Abdominal and Thoracic Aorta - Study "Micro AAA"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

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

Primary outcomes:
measure: Difference in levels of circulating miRNAs
timeFrame: March 2017
measure: Correlation between the level of the circulating miRNAs and the maximal diameter of the aneurysm sac.
timeFrame: March 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Charles University in Prague
Study officials:
References: