Aortic AneurysmNCT03090763
Role of Circulating MicroRNAs in Pathogenesis of Aneurysms of the Abdominal and Thoracic Aorta - Study "Micro AAA"
An observational study of Aortic Aneurysm, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- PCR and sequencing
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2016to 1 Jun 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
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- signed informed consent for participation in the study;
- age above 18 years;
- absence of a thoracic or abdominal aortic aneurysm (TAA or AAA).
Who cannot join
- life expectation above one year;
- history of myocardial infarction or unstable angina pectoris 1 month ago.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Charles University in Prague
Prague, 12808
Jean Claude Lubanda, Ass.Prof.MD, +420224962692, Jean-Claude.Lubanda@vfn.cz
Martina Striteska, Mgr., +224962605, Martina.Striteska@vfn.cz
About this study
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.
Read the 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.
- Conditions
- Aortic Aneurysm
- Being tested
- PCR and sequencing
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR and sequencingGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Study population | 100 Subjects followed in our department for the diagnosis of aortic aneurysm. On admission, the demographic data (see Appendix 1) will be recorded. Furthermore, within the routine clinically indicated laboratory samples, the levels of selected biochemical markers will be recorded (see Appendix 1). Follow up control laboratory will be performed one year, again within the routine samples. Receives: Genetic: PCR and sequencing | |
| Control population | The control population also includes 100 subjects in total. These will be chosen from aged and sex matched individuals seen in our clinic without disease of the aorta. All subjects included in trial must be at least 18 years old and must sign the informed consent to participation in the study. In the control population, also demographic data will be obtained and the levels of selected biochemical markers will be recorded within the routine clinically indicated laboratory samples. Receives: Genetic: PCR and sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in levels of circulating miRNAs
Difference 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.
Measured: March 2017
Correlation between the level of the circulating miRNAs and the maximal diameter of the aneurysm sac.
Correlation between the level of the circulating miRNAs and the maximal diameter of the aneurysm sac.
Measured: March 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Nov 2016
- Primary completion1 May 2018 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ass. prof. Jean-Claude M. Lubanda, MD, Ph.D, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090763
- Sponsor's protocol ID
- Micro AAA
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Circulating MicroRNAs in Pathogenesis of Aneurysms of the Abdominal and Thoracic Aorta - Study "Micro AAA"
- ClinicalTrials.gov ID
- NCT03090763
- Acronym / sponsor ID
- Micro AAA
- Conditions
- Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 27 Mar 2017 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Genetic: PCR and sequencing100 Subjects followed in our department for the diagnosis of aortic aneurysm. On admission, the demographic data (see Appendix 1) will be recorded. Furthermore, within the routine clinically indicated laboratory samples, the levels of selected biochemical markers will be recorded (see Appendix 1). Follow up control laboratory will be performed one year, again within the routine samples. |
| Control population | – | Genetic: PCR and sequencingThe control population also includes 100 subjects in total. These will be chosen from aged and sex matched individuals seen in our clinic without disease of the aorta. All subjects included in trial must be at least 18 years old and must sign the informed consent to participation in the study. In the control population, also demographic data will be obtained and the levels of selected biochemical markers will be recorded within the routine clinically indicated laboratory samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
- signed informed consent for participation in the study;
Key exclusion criteria (2 listed)
- life expectation above one year;
- history of myocardial infarction or unstable angina pectoris 1 month ago.
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 |
|---|---|---|
| PCR and sequencingBlood 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. | Genetic | Control population, Study population |
Primary outcome
Difference in levels of circulating miRNAs
Time frame: March 2017
Difference 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.
Time frame: March 2017
Correlation between the level of the circulating miRNAs and the maximal diameter of the aneurysm sac.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Individual participant dataSharing planned: No
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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.
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 Aortic Aneurysm, run by Charles University, Czech Republic 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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Mar 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Claude Lubanda, MD., Ph.D. (00420224962692, Jean-Claude.Lubanda@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in levels of circulating miRNAs (time frame: March 2017). The study lists 2 primary outcomes in all. 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 27 Mar 2017.