Abdominal AneurysmNCT07236281
Selenium Levels in Patients With Abdominal Aneurysm
An observational study of Abdominal Aneurysm and Selenium Deficiency, run by Comenius University at 1 site in Slovakia.
Trial summary
Retrospective study comparing the selenium level in patients with abdominal aortic aneurysm with the selenium level in patients in the control group, i.e., patients without aneurysmal changes of the abdominal aorta. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aneurysm, Selenium Deficiency
- How many people
- 40 participants
- Where
- 1 siteSlovakia
- Study dates
- 15 Jan 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study group comprises of 40 subjects. Twenty are cases, these are patients with AAA that was confirmed by radiology. The AAA was not treated by surgery or endovascular intervention. The are followed for the AAA by vascular surgery outpatient office. Controls are twenty persons without AAA, as confirmed by ultrasonography. They are followed by vascular surgery outpatient office for other vascular diseases. Both cases and controls are taken a blood sample, in which blood selenium level is established. Odds ratio will be calculated of having low than normal blood selenium levels in cases versus controls.
Who may be able to join
- cases - patients with AAA (confirmed by radiology) followed by vascular surgery outpatient office that signed informed consent. The AAA was not treated by surgery or endovascular intervention
- controls - people without AAA (confirmed by ultrasonography) followed by vascular surgery outpatient office for other vascular disease that signed informed consent
Who cannot join
- patients that had AAA treated by surgery or endovascular intervention
- persons that did not sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selenium Levels in Patients With Abdominal Aortic Aneurysm
Retrospective study comparing the selenium level in patients with abdominal aortic aneurysm with the selenium level in patients in the control group, i.e., patients without aneurysmal changes of the abdominal aorta.
Read the detailed description
Selenium (Se), incorporated into selenocysteine, is an essential component of selenoproteins. These proteins play a crucial role in vascular protection by reducing oxidative stress, regulating inflammation, supporting endothelial nitric oxide signalling, and maintaining smooth muscle cell homeostasis. Insufficient selenoprotein activity contributes to vascular dysfunction and weakening of the vessel wall.
The aim of this project is to investigate a potential association between reduced selenium levels and abdominal aortic aneurysm (AAA) of degenerative origin.
The study group will include 20 individuals with an abdominal aortic aneurysm measuring at least 35 millimeters in diameter, verified by a radiologist using standard diagnostic imaging methods (ultrasound, CT angiography, or digital subtraction angiography). The control group will comprise 20 individuals without an abdominal aortic aneurysm. Selenium blood levels will be measured in both groups, and the relationship between selenium status and the presence of AAA will be evaluated using biostatistical analysis.
- Conditions
- Abdominal Aneurysm, Selenium Deficiency
- Keywords
- abdominal aortic aneurysm, selenium deficiency
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases - persons with abdominal aortic aneurysm | Persons with abdominal aortic aneurysm (AAA) of minimally 35 mm diameter, followed by vascular surgery outpatient office. AAA is verified by radiology, was not treated by surgical or endovascular intervention. | |
| Controls - persons without abdominal aortic aneurysm | Persons without abdominal aortic aneurysm (AAA), as confirmed by ultrasonography. Controls will be recruited from vascular surgery outpatient office, in treatment for other vascular conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds Ratio
Odds Ratio - odds of having lower than normal selenium levels in cases compared to the same odds in controls
Measured: From enrollment to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Jan 2025
- Primary completion15 Sep 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bratislava
- Responsible party
- Principal investigator, Alexandra Brazinova, Comenius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236281
- Sponsor's protocol ID
- EK 1/11/2024
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenium Levels in Patients With Abdominal Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT07236281
- Acronym / sponsor ID
- EK 1/11/2024
- Conditions
- Abdominal Aneurysm, Selenium Deficiency
- Keywords
- abdominal aortic aneurysm, selenium deficiency
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Collaborators
- University Hospital Bratislava
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
Retrospective study comparing the selenium level in patients with abdominal aortic aneurysm with the selenium level in patients in the control group, i.e., patients without aneurysmal changes of the abdominal aorta.
Detailed description
Selenium (Se), incorporated into selenocysteine, is an essential component of selenoproteins. These proteins play a crucial role in vascular protection by reducing oxidative stress, regulating inflammation, supporting endothelial nitric oxide signalling, and maintaining smooth muscle cell homeostasis. Insufficient selenoprotein activity contributes to vascular dysfunction and weakening of the vessel wall.
The aim of this project is to investigate a potential association between reduced selenium levels and abdominal aortic aneurysm (AAA) of degenerative origin.
The study group will include 20 individuals with an abdominal aortic aneurysm measuring at least 35 millimeters in diameter, verified by a radiologist using standard diagnostic imaging methods (ultrasound, CT angiography, or digital subtraction angiography). The control group will comprise 20 individuals without an abdominal aortic aneurysm. Selenium blood levels will be measured in both groups, and the relationship between selenium status and the presence of AAA will be evaluated using biostatistical analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases - persons with abdominal aortic aneurysm | – | –Persons with abdominal aortic aneurysm (AAA) of minimally 35 mm diameter, followed by vascular surgery outpatient office. AAA is verified by radiology, was not treated by surgical or endovascular intervention. |
| Controls - persons without abdominal aortic aneurysm | – | –Persons without abdominal aortic aneurysm (AAA), as confirmed by ultrasonography. Controls will be recruited from vascular surgery outpatient office, in treatment for other vascular conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group comprises of 40 subjects. Twenty are cases, these are patients with AAA that was confirmed by radiology. The AAA was not treated by surgery or endovascular intervention. The are followed for the AAA by vascular surgery outpatient office. Controls are twenty persons without AAA, as confirmed by ultrasonography. They are followed by vascular surgery outpatient office for other vascular diseases. Both cases and controls are taken a blood sample, in which blood selenium level is established. Odds ratio will be calculated of having low than normal blood selenium levels in cases versus controls.
Key inclusion criteria (2 listed)
- cases - patients with AAA (confirmed by radiology) followed by vascular surgery outpatient office that signed informed consent. The AAA was not treated by surgery or endovascular intervention
- controls - people without AAA (confirmed by ultrasonography) followed by vascular surgery outpatient office for other vascular disease that signed informed consent
Key exclusion criteria (2 listed)
- patients that had AAA treated by surgery or endovascular intervention
- persons that did not sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Odds Ratio
Time frame: From enrollment to 12 months after enrollment
Odds Ratio - odds of having lower than normal selenium levels in cases compared to the same odds in controls
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- 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.
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 Abdominal Aneurysm and Selenium Deficiency, run by Comenius University at 1 site in Slovakia.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. 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 Slovakia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Odds Ratio (time frame: From enrollment to 12 months after enrollment). 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 Nov 2025.