NCT07236281

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jan 2025Jun 2026

Study Start

First participant enrolled

January 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

November 15, 2025

Last Update Submit

November 15, 2025

Conditions

Keywords

abdominal aortic aneurysmselenium deficiency

Outcome Measures

Primary Outcomes (1)

  • Odds Ratio

    Odds Ratio - odds of having lower than normal selenium levels in cases compared to the same odds in controls

    From enrollment to 12 months after enrollment

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • patients that had AAA treated by surgery or endovascular intervention
  • persons that did not sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bratislava

Bratislava, 85107, Slovakia

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Institute of Epidemiology, Faculty of Medicine

Study Record Dates

First Submitted

November 15, 2025

First Posted

November 19, 2025

Study Start

January 15, 2025

Primary Completion

September 15, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations