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

NCT ID: NCT05617326

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2027-09-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

screening by a GP

Each patient in this group will have a screening for AAA performed by a trained general practitioner

Group Type: EXPERIMENTAL

AAA screening by a GP

Intervention Type: OTHER

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..

screening by a radiologist (conventional)

Each patient in this group will have AAA screening performed by a radiologist

Group Type: OTHER

AAA screening by a radiologist

Intervention Type: OTHER

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

Interventions

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..

Intervention Type: OTHER

AAA screening by a radiologist

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male
• In the absence of a family history of AAA: Patient aged 65 to 75 years, chronic current or past smoker, active smoker (defined as having smoked at least one cigarette per day) or former smoker (defined as having quit smoking less than 20 years ago, regardless of the number of cigarettes smoked).
• If there is a family history of AAA: Patient between 50 and 75 years of age
• Express consent to participate in the study
• Affiliated or beneficiary of a social security plan

Exclusion Criteria

• Patient with a legal protection measure
• Patient with previous AAA screening less than 5 years old
• Patient unable to understand the study / give informed consent (cognitive impairment, communication impairment)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé Picard, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation A. de Rothschild

Locations

Cabinet IPSO Brotteaux

Lyon, , France

Site Status: RECRUITING

Cabinet IPSO Saint Martin

Paris, , France

Site Status: RECRUITING

Cabinet IPSO Nation

Paris, , France

Site Status: RECRUITING

Cabinet IPSO Italie

Paris, , France

Site Status: RECRUITING

Cabinet IPSO Ourcq

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amélie YAVCHITZ, MD

Role: CONTACT

ayavchitz@for.paris

148036454 ext. +33

Facility Contacts

Adrien NAEGELEN, Dr

Role: primary

adrien.naegelen@ipsosante.fr

+33428290929

Hervé PICARD, Dr

Role: primary

herve.picard@ipso.paris

01 84 20 20 20

Inès DUMORTIER, Dr

Role: primary

ines.dumortier@ipsosante.fr

+33180407777

Roxane LIARD, Dr

Role: primary

roxane.liard@ipsosante.fr

01 84 20 20 15

Laurène BERNARD, Dr

Role: primary

laurene.bernard@ipsosante.fr

Other Identifiers

HPD_2022_8

Identifier Type: -

Identifier Source: org_study_id