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

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Abdominal aortic aneurysm
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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