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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098523
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Erik Debing, Universitair Ziekenhuis Brussel

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.


Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Abdominal Aortic Aneurysm Epidemiology Diagnostic Test: Duplex ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4680 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Prevalence of CAS and AAA among 60+ Brussels inhabitants. [ Time Frame: Screening period of 2 years ]
    Determine the prevalence using echo duplex screening.

  2. 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, …)
    • Hypercholesterolemia
    • Body weight & length (BMI)
    • COPD



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

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


Contacts
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Contact: Mieke Tempels, MSc 0032 11 28 69 48 mieke.tempels@archerresearch.eu
Contact: Karen Gabriels, PhD 0032 11 28 69 27 karen.gabriels@archerresearch.eu

Locations
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Belgium
UZ Brussel
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.         
Sponsors and Collaborators
Erik Debing
Investigators
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Principal Investigator: Erik Debing, Prof. Dr. Universitair Ziekenhuis Brussel

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Responsible Party: Erik Debing, Head of the Department of Vascular Surgery Professor Doctor Erik Debing, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04098523    
Other Study ID Numbers: GALSKELA01
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erik Debing, Universitair Ziekenhuis Brussel:
Carotid Artery Stenosis
Abdominal Aortic Aneurysm
Epidemiology
Stenosis
Population screening
Additional relevant MeSH terms:
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Carotid Stenosis
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Constriction, Pathologic
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases