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

NCT ID: NCT04098523

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Carotid Artery Stenosis Abdominal Aortic Aneurysm Epidemiology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Duplex ultrasound

Intervention Type 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.

Interventions

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Duplex 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erik Debing

OTHER

Sponsor Role lead

Responsible Party

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Erik Debing

Head of the Department of Vascular Surgery Professor Doctor Erik Debing

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Erik Debing, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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UZ Brussel

Jette, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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GALSKELA01

Identifier Type: -

Identifier Source: org_study_id

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