Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.
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|ClinicalTrials.gov Identifier: NCT04098523|
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis Abdominal Aortic Aneurysm Epidemiology||Diagnostic Test: Duplex ultrasound||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||4680 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||December 2021|
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.
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.
- Prevalence of CAS and AAA among 60+ Brussels inhabitants. [ Time Frame: Screening period of 2 years ]Determine the prevalence using echo duplex screening.
- Risk factors associated with CAS and AAA among 60+ Brussels inhabitants. [ Time Frame: Screening period of 2 years ]
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, …)
- Body weight & length (BMI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098523
|Contact: Mieke Tempels, MSc||0032 11 28 69 email@example.com|
|Contact: Karen Gabriels, PhD||0032 11 28 69 firstname.lastname@example.org|
|Jette, Belgium, 1090|
|Contact: Sarah Gallala, Dr.|
|Contact: Laura Kerselaers, Dr.|
|Sub-Investigator: Sarah Gallala, Dr.|
|Sub-Investigator: Laura Kerselaers, Dr.|
|Principal Investigator: Erik Debing, Prof. Dr.|
|Principal Investigator:||Erik Debing, Prof. Dr.||Universitair Ziekenhuis Brussel|