Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
MALE
Healthy Volunteers
NCT05617326

Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound

Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2025-12-17

400

Participants Needed

5

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Abdominal aortic aneurysm (AAA) is a localized dilatation of a segment of the aorta artery in its abdominal portion. It affects 1.7% of men aged 65 years and older. In the high-risk population (male smokers aged 65-75 years), its prevalence is estimated to be between 2.8 and 9%. Mortality of ruptured AAAs is high (80% of deaths before hospitalization or perioperatively), whereas mortality of scheduled procedures for unruptured AAAs is less than 5%. AAA screening has been shown to significantly reduce the specific mortality rate in the medium and long term. The French National Authority for Health (HAS) recommends targeted screening for AAA by ultrasound at the radiologist. The target population is male smokers or former smokers aged 65 to 75 years, as well as all persons aged 50 to 75 years with a family history of AAA. Despite recommendations, the rate of access to targeted screening appears low. Ultrasound screening for AAA is a rapid, noninvasive, and reproducible test. It relies primarily on the measurement of the maximum diameter of the abdominal aorta in cross-section. It has been demonstrated that the learning of the ultrasound screening procedure for AAA is very fast and that the performance of non-radiologists trained in this procedure alone is similar to that of radiologists. In addition, new ultra-portable ultrasound devices, inexpensive and with validated performances have appeared on the market in the last few years, making it possible to equip general practitioners (GPs). We propose a simplified care pathway for AAA screening, by equipping GPs with an ultra-portable ultrasound scanner and by training them to perform the screening procedure, which will be performed in the office or at the patient's home, during a usual consultation of general medicine. Our hypothesis is that this new organization will allow better access to screening for the target population, at a lower cost, compared to the current screening method recommended by the HAS (referral of the patient to the radiologist).

CONDITIONS

Official Title

Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound

Who Can Participate

Age: 50Years - 75Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male
  • If no family history of AAA: Age 65 to 75 years and current smoker or former smoker who quit less than 20 years ago
  • If family history of AAA: Age 50 to 75 years
  • Able to give consent to participate in the study
  • Affiliated with or beneficiary of a social security plan
Not Eligible

You will not qualify if you...

  • Under legal protection measures
  • Previous AAA screening within the last 5 years
  • Unable to understand the study or give informed consent due to cognitive or communication issues

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Trial Site Locations

Total: 5 locations

1

Cabinet IPSO Brotteaux

Lyon, France, 69006

Actively Recruiting

2

Cabinet IPSO Saint Martin

Paris, France, 75003

Actively Recruiting

3

Cabinet IPSO Nation

Paris, France, 75011

Actively Recruiting

4

Cabinet IPSO Italie

Paris, France, 75013

Actively Recruiting

5

Cabinet IPSO Ourcq

Paris, France, 75019

Actively Recruiting

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Research Team

A

Amélie YAVCHITZ, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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