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Completed

NCT Number: NCT04098523

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Duplex ultrasound

Diagnostic Test

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.

Primary outcomes

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

    Time frame: Screening period of 2 years

    Determine the prevalence using echo duplex screening.

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

    Time frame: Screening period of 2 years

    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

Sponsors and collaborators

Lead sponsor

Erik Debing

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2019
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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