Role of Circulating MicroRNAs in Pathogenesis of Aneurysms of the Abdominal and Thoracic Aorta - Study "Micro AAA"
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMarch 27, 2017
March 1, 2017
1.5 years
March 20, 2017
March 20, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
March 2017
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
* 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.
You may qualify if:
- 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).
You may not qualify if:
- life expectation above one year;
- history of myocardial infarction or unstable angina pectoris 1 month ago.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charles University in Prague
Prague, 12808, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass.prof.
Study Record Dates
First Submitted
March 20, 2017
First Posted
March 27, 2017
Study Start
November 1, 2016
Primary Completion
May 1, 2018
Study Completion
June 1, 2019
Last Updated
March 27, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share