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

Abdominal Aortic Aneurysm Clinical Trial

— DACEP  

Official title:

Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound: Cluster Randomized Controlled Prospective Multicenter Study in Two Parallel Groups 1:1 in Open-label

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617326
• Other study ID #: HPD_2022_8
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie YAVCHITZ, MD
• Phone: 148036454
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
France	Cabinet IPSO Italie	Paris
France	Cabinet IPSO Nation	Paris
France	Cabinet IPSO Ourcq	Paris
France	Cabinet IPSO Saint Martin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AAA screening performed at 1 year	Percentage of included patients (eligible for AAA screening) who actually received AAA screening ultrasound within 1 year of the inclusion visit	1 year