- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236281
Selenium Levels in Patients With Abdominal Aneurysm
Selenium Levels in Patients With Abdominal Aortic Aneurysm
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bratislava, Slovakia, 85107
- University Hospital Bratislava
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients that had AAA treated by surgery or endovascular intervention
- persons that did not sign informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Odds Ratio
Time Frame: From enrollment to 12 months after enrollment
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Odds Ratio - odds of having lower than normal selenium levels in cases compared to the same odds in controls
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From enrollment to 12 months after enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK 1/11/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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