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CompletedNCT04098523Updated Feb 9, 2024

Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.

An interventional study of Duplex ultrasound in Carotid Artery Stenosis, Abdominal Aortic Aneurysm and Epidemiology, sponsored by Erik Debing. Completed at 1 site in Belgium. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Erik Debing · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
3,286
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study summary

Both abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS) are frequent clinical entities, with major morbidity and mortality.

This project obtains robust data on the prevalence of AAA and CAS in the Brussels Capital Region. Using duplex ultrasound, a low invasive examination, we want to obtain information on a vast sample of men and women of the Brussels capital region, starting at the age of 60. With these data we can have a far better view on the Belgian situation of these two main vascular clinical entities. The data can provide insights on if, and how, Belgian public health policy can be improved concerning AAA and CAS.

Read the detailed description

A population-based screening study to determine the prevalence of carotid artery stenosis (CAS) and abdominal aortic aneurysms (AAA) in the Brussels Capital Region.

The study population is the 60+ inhabitants of the Brussels capital region; recruitment of 4680 subjects. Using duplex ultrasound, a low invasive examination, information is obtained on the abdominal aortic diameter and the degree of stenosis of the carotid bifurcation.

The objective is to determine not only the prevalence of, but also the risk factors associated with CAS and AAA among 60+ Brussels inhabitants. To collect these data, a questionnaire is made including demographic features, associated risk factors, but also previous treatment for AAA or CAS and the current medication of the subject.

Examination is done by one-time duplex ultrasound to perform a diameter measurement of the abdominal aorta and determine the degree of stenosis of the carotid arteries.

Data collection will be done in an electronic case report form, and statistical analysis will be done by a multi-variable logistic regression model.

02

Conditions studied

  • Carotid Artery Stenosis
  • Abdominal Aortic Aneurysm
  • Epidemiology

Keywords

  • Carotid Artery Stenosis
  • Abdominal Aortic Aneurysm
  • Epidemiology
  • Stenosis
  • Population screening
03

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's enrollment of 3,286 is above the median of 106 across 182 interventional studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

This is the only study on the registry with Erik Debing as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Candidate is at least 60 years old.
  2. Candidate lives in Brussels capital region at the time of study participation.
  3. Candidate must sign and date the informed consent form prior to study participation.

Exclusion criteria

Exclusion Criteria:

  1. Candidate is suspected of being unable to comply with the study protocol.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,286 participants (actual)

Study arms

  • Other
    Epidemiologic screening

    All subjects are screened by duplex ultrasound for abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS). A questionnaire is completed to obtain information on demographic information, risk factors as well as prior treatment for AAA or CAS and current medication. No treatment is given.

    Diagnostic Test: Duplex ultrasound

Interventions

  • Diagnostic testDuplex ultrasound

    A one-time carotis and abdominal aorta duplex ultrasound will be performed on-site by a skilled site staff to determine the prevalence of, and risk factors associated with, CAS and AAA. A diameter measurement will be performed of the abdominal aorta as well as a determination of the carotid arteries.

06

What researchers measure

Primary outcomes

  1. Prevalence of CAS and AAA among 60+ Brussels inhabitants.

    Determine the prevalence using echo duplex screening.

    Time frame: Screening period of 2 years

  2. Risk factors associated with CAS and AAA among 60+ Brussels inhabitants.

    Determine the risk factors via a questionnaire: * Smoking (ex - current - none) * Hypertension (medical history - current) * Coronary Artery Disease (history of angina pectoris or myocardial infarction) * Diabetes Mellitus (history of diet or medically-treated diabetes - type I or II) * History of Cerebro Vascular Disease (stroke or TIA) * Family (parents/siblings) history (AAA, CVD, ...) * Hypercholesterolemia * Body weight \& length (BMI) * COPD

    Time frame: Screening period of 2 years

07

Study locations

1 site
  • UZ Brussel
    Jette, 1090, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04098523
Lead sponsor
Erik Debing
Responsible party
Erik Debing (Head of the Department of Vascular Surgery Professor Doctor Erik Debing, Universitair Ziekenhuis Brussel) — Sponsor-investigator
First posted
Sep 23, 2019
Start date
Jan 1, 2020
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Feb 9, 2024

Study contacts

Erik Debing, Prof. Dr.
principal investigator · Universitair Ziekenhuis Brussel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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