miRNA in Patients With Thoracic, Abdominal and Intracranial Aneurysms (miRNA)

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.

Study Overview

• Status: Completed
• Conditions: Vascular Aneurysm
• Intervention / Treatment: Diagnostic test: ngs next generation sequencing

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 15030
    • Na Homolce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study group will be made up of 50 subjects followed for the diagnosis of AAA or TAA and 20 patients with intracranial aneurysm. The control group comprises 20 subjects in total and will be made up of patients who are treated for lipid metabolism disorder

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients Controls; Control group	Diagnostic test: ngs next generation sequencing; the samples from aneurysmatic tissue and healthy aortic tissue will be investigated using NGS
Patients with aneurysma	Diagnostic test: ngs next generation sequencing; the samples from aneurysmatic tissue and healthy aortic tissue will be investigated using NGS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Na Homolce Hospital
• Collaborators: Czech Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: miRNA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: IG144101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No