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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05382611
Other study ID # IG144101
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 19, 2018
Est. completion date December 31, 2021

Study information

Verified date May 2022
Source Na Homolce Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess the expression of miRNA in patients with TAA, AAA in aneurysmatic tissue and to compare this expression with the healthy tissue in the same patient. In the same cohort, to asses the presence of miRNA in plasma and to compare with the control group. Over the period of three years,to follow subjects in order to assess if the presence of certain miRNAs speeds up or slows down the progression of disease. In patients with intracranial aneurysms to detect miRNA in plasma especially in patients with familial occurrence.


Description:

MicroRNAs constitute a recently discovered class of non-coding RNAs that play key roles in the regulation of gene expression. Acting at the post-transcriptional level, MicroRNAs have been shown to be involved in a wide range of biological processes such as cell cycle control, apoptosis and several developmental and physiological processes including stem cell differentiation, hematopoiesis, hypoxia, cardiac and skeletal muscle development. In addition to their important roles in healthy individuals, microRNAs have also been implicated in a number of diseases including a broad range of cancers, cardiovascular and heart disease. Their different expression in aortic tissue in patients with aortic abdominal aneurysm and their association with the progression of the disease were confirmed. They represent the potential target for the treatment of the disease. MiRNA act as biomarkers showing the potential risk of the presence of TAA, AAA and intracranial aneurysm, for the prediction of TAA and AAA progression and for the discovery of new treatment possibilities.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. 18 years of age or older 2. Patient willing and able to sign clinical trial Informed Consent 3. Patient with AAA or TAA who require an open surgical procedure, or patient with intracranial aneurysm indicated for radiological intervention Exclusion Criteria: 1. Patient with multiorgan failure

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ngs next generation sequencing
the samples from aneurysmatic tissue and healthy aortic tissue will be investigated using NGS

Locations

Country Name City State
Czechia Na Homolce Hospital Prague

Sponsors (2)

Lead Sponsor Collaborator
Na Homolce Hospital Czech Academy of Sciences

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary The comparison of miRNA in healthy and aneurysmatic tissue miRNA will be compared in blood and in healthy and aneurysmatic tissue using ngs 2020 at end of trial
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