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

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098523
• Other study ID #: GALSKELA01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3286
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic
• Epidemiology

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Erik Debing

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of CAS and AAA among 60+ Brussels inhabitants.	Determine the prevalence using echo duplex screening.	Screening period of 2 years
Primary	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	Screening period of 2 years