Brief Title
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.
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.
Study Type
Interventional
Primary Outcome
Prevalence of CAS and AAA among 60+ Brussels inhabitants.
Condition
Carotid Artery Stenosis
Intervention
Duplex ultrasound
Study Arms / Comparison Groups
Epidemiologic screening
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
4680
Start Date
November 2019
Completion Date
December 2021
Primary Completion Date
November 2021
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.
Gender
All
Ages
60 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Erik Debing, Prof. Dr., 0032 11 28 69 48, [email protected]
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT04098523
Organization ID
GALSKELA01
Responsible Party
Sponsor-Investigator
Study Sponsor
Erik Debing
Study Sponsor
Erik Debing, Prof. Dr., Principal Investigator, Universitair Ziekenhuis Brussel
Verification Date
September 2019