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

NCT05617326 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-17

No results posted yet for this study

Summary

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

  • Abdominal Aortic Aneurysm

Interventions

OTHER

AAA screening by a radiologist

General practitioners in the control group will refer their patients to the radiologist for AAA screening.

OTHER

AAA screening by a GP

The GPs included in the experimental group will be trained in AAA screening with an ultra-portable ultrasound machine and will keep an ultrasound machine available (Butterfly iQ+ model). Their patients will be able to be screened by the GP in the office or at home. In case of positive screening, the GP will be able to refer the patients to the radiologist for diagnostic confirmation..

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Hervé Picard, MD · Hôpital Fondation A. de Rothschild

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-02
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05617326 on ClinicalTrials.gov