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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
France
Cabinet IPSO Italie
ACTIVE_NOT_RECRUITING
Paris
Cabinet IPSO Nation
ACTIVE_NOT_RECRUITING
Paris
Cabinet IPSO Ourcq
RECRUITING
Paris
Cabinet IPSO Saint Martin
RECRUITING
Paris
Contact Information
Primary
Amélie YAVCHITZ, MD
ayavchitz@for.paris
148036454
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 400
Treatments
Experimental: screening by a GP
Each patient in this group will have a screening for AAA performed by a trained general practitioner
Other: screening by a radiologist (conventional)
Each patient in this group will have AAA screening performed by a radiologist
Sponsors
Leads: Fondation Ophtalmologique Adolphe de Rothschild

This content was sourced from clinicaltrials.gov