Clinical trial NCT04098523: Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.
Official title: Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Stenosis
Abdominal Aortic Aneurysm
Epidemiology
Keywords: Carotid Artery Stenosis
Abdominal Aortic Aneurysm
Epidemiology
Stenosis
Population screening
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 3286
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of CAS and AAA among 60+ Brussels inhabitants.
timeFrame: Screening period of 2 years
measure: Risk factors associated with CAS and AAA among 60+ Brussels inhabitants.
timeFrame: Screening period of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Erik Debing, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: