Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.
Primary Purpose
Carotid Artery Stenosis, Abdominal Aortic Aneurysm, Epidemiology
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Duplex ultrasound
Sponsored by
About this trial
This is an interventional screening trial for Carotid Artery Stenosis focused on measuring Carotid Artery Stenosis, Abdominal Aortic Aneurysm, Epidemiology, Stenosis, Population screening
Eligibility Criteria
Inclusion Criteria:
- Candidate is at least 60 years old.
- Candidate lives in Brussels capital region at the time of study participation.
- 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.
Sites / Locations
- UZ BrusselRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Epidemiologic screening
Arm 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.
Outcomes
Primary Outcome Measures
Prevalence of CAS and AAA among 60+ Brussels inhabitants.
Determine the prevalence using echo duplex screening.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04098523
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erik Debing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis, Abdominal Aortic Aneurysm, Epidemiology
Keywords
Carotid Artery Stenosis, Abdominal Aortic Aneurysm, Epidemiology, Stenosis, Population screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4680 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epidemiologic screening
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Duplex ultrasound
Intervention Description
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 Measure Information:
Title
Prevalence of CAS and AAA among 60+ Brussels inhabitants.
Description
Determine the prevalence using echo duplex screening.
Time Frame
Screening period of 2 years
Title
Risk factors associated with CAS and AAA among 60+ Brussels inhabitants.
Description
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
Time Frame
Screening period of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Candidate is at least 60 years old.
Candidate lives in Brussels capital region at the time of study participation.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mieke Tempels, MSc
Phone
0032 11 28 69 48
Email
mieke.tempels@archerresearch.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Gabriels, PhD
Phone
0032 11 28 69 27
Email
karen.gabriels@archerresearch.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Debing, Prof. Dr.
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Gallala, Dr.
First Name & Middle Initial & Last Name & Degree
Laura Kerselaers, Dr.
First Name & Middle Initial & Last Name & Degree
Sarah Gallala, Dr.
First Name & Middle Initial & Last Name & Degree
Laura Kerselaers, Dr.
First Name & Middle Initial & Last Name & Degree
Erik Debing, Prof. Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.
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