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

NCT04098523 | Completed

• 1 other identifier: GALSKELA01
• Study Type: interventional
• Target: 3,286
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Stenosis; Abdominal Aortic Aneurysm; Epidemiology

Keywords

Carotid Artery Stenosis; Abdominal Aortic Aneurysm; Epidemiology; Stenosis; Population screening

Outcome Measures

Primary Outcomes (2)

• Prevalence of CAS and AAA among 60+ Brussels inhabitants.

  Determine the prevalence using echo duplex screening.

  Screening period of 2 years

• 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

  Screening period of 2 years

Study Arms (1)

Epidemiologic screening

OTHER

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

Interventions

Duplex ultrasound DIAGNOSTIC_TEST

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.

Epidemiologic screening

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Candidate is suspected of being unable to comply with the study protocol.

Sponsors & Collaborators

• Erik Debing: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Carotid Stenosis; Aortic Aneurysm, Abdominal; Constriction, Pathologic

Interventions

Ultrasonography, Doppler, Duplex

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aneurysm; Aortic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Erik Debing, Prof. Dr.

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Department of Vascular Surgery Professor Doctor Erik Debing

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 23, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)