Vascular AneurysmmiRNANCT05382611
miRNA in Patients With Thoracic, Abdominal and Intracranial Aneurysms
An observational study of Vascular Aneurysm, run by Na Homolce Hospital at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Aneurysm
- What is being tested?
- ngs next generation sequencing
- How many people
- 35 participants
- Where
- 1 siteCzechia
- Study dates
- 19 May 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 18 years of age or older
- Patient willing and able to sign clinical trial Informed Consent
- Patient with AAA or TAA who require an open surgical procedure, or patient with intracranial aneurysm indicated for radiological intervention
Who cannot join
- 1. Patient with multiorgan failure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vascular Aneurysm
- Being tested
- ngs next generation sequencing
- Keywords
- miRNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ngs next generation sequencingDiagnostic test
the samples from aneurysmatic tissue and healthy aortic tissue will be investigated using NGS
| Study group | Role | What they receive |
|---|---|---|
| Patients Controls | Control group Receives: Diagnostic Test: ngs next generation sequencing | |
| Patients with aneurysma | Patients with aneurysma Receives: Diagnostic Test: ngs next generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of miRNA in healthy and aneurysmatic tissue
miRNA will be compared in blood and in healthy and aneurysmatic tissue using ngs
Measured: 2020 at end of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start19 May 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Na Homolce Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Czech Academy of Sciences
- Responsible party
- Principal investigator, Assoc. Prof. Miroslav Prucha, M.D., PhD., Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382611
- Sponsor's protocol ID
- IG144101
- Acronym
- miRNA
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- miRNA in Patients With Thoracic, Abdominal and Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT05382611
- Acronym / sponsor ID
- miRNA / IG144101
- Conditions
- Vascular Aneurysm
- Keywords
- miRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Na Homolce HospitalUniversity, hospital or other
- Collaborators
- Czech Academy of Sciences
- Study start
- 19 May 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Controls | – | Diagnostic Test: ngs next generation sequencingControl group |
| Patients with aneurysma | – | Diagnostic Test: ngs next generation sequencingPatients with aneurysma |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patient willing and able to sign clinical trial Informed Consent
- Patient with AAA or TAA who require an open surgical procedure, or patient with intracranial aneurysm indicated for radiological intervention
Key exclusion criteria (1 listed)
- 1. Patient with multiorgan failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ngs next generation sequencingthe samples from aneurysmatic tissue and healthy aortic tissue will be investigated using NGS | Diagnostic test | Patients Controls, Patients with aneurysma |
Primary outcome
The comparison of miRNA in healthy and aneurysmatic tissue
Time frame: 2020 at end of trial
miRNA will be compared in blood and in healthy and aneurysmatic tissue using ngs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Aneurysm, run by Na Homolce Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison of miRNA in healthy and aneurysmatic tissue (time frame: 2020 at end of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.