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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03090763
Enrollment
200
Registered
2017-03-27
Start date
2016-11-01
Completion date
2019-06-01
Last updated
2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic 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.

Interventions

GENETICPCR and sequencing

Blood will be subsequently added into a test tube containing RNA solution of a stabilizer, necessary for preservation of the circulating miRNAs. Subsequently, centrifugation will be performed in a cooled centrifuge and the material thus processed will be kept for the subsequent isolation. The isolation of miRNA will be performed using the High Pure miRNA Isolation Kit (Roche, Basel, CHE) according to the manufacturer's standardized procedure. Presence and quality of the miRNA isolated will be spectrophotometrically confirmed using the NanoDrop device (ThermoScientific, Wilmington, DE, USA). By means of the data available in the on-line gene data basis, primers that are necessary for amplification of miRNA through the RT-PCR method using fluorescent dyes will be suggested.

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in levels of circulating miRNAsMarch 2017Difference 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.
Correlation between the level of the circulating miRNAs and the maximal diameter of the aneurysm sac.March 2017Correlation between the level of the circulating miRNAs and the maximal diameter of the aneurysm sac.

Countries

Czechia

Contacts

Primary ContactJean Claude Lubanda, MD., Ph.D.
Jean-Claude.Lubanda@vfn.cz00420224962692

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026