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

Erik Debing

Status: Completed

Conditions: Carotid Artery Stenosis; Abdominal Aortic Aneurysm; Epidemiology

Treatments: Diagnostic Test: Duplex ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04098523

GALSKELA01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,286 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,286 participants in 1 patient group

Epidemiologic screening

Other group

Description:

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.

Treatment:

Diagnostic Test: Duplex ultrasound