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

Study acronym: DACEP
StatusRecruiting
PhaseNot applicable
Started2023-10-02
View on ClinicalTrials.gov ↗

Amendment history

2025-12-09
minor
Study Status, Contacts/Locations v7
Primary completion date2025-10-01→2027-09-01
Completion date2025-10-01→2027-09-01
Study sites4→5
2024-12-03
minor
Study Status v6
Re-verified, no change to tracked fields
2023-10-25
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-08-08→2025-10-01
Completion date2026-08-08→2025-10-01
Start dateestimated 2023-08-08→confirmed 2023-10-02
Study sites0→4
2023-07-27
minor
Study Status v4
Primary completion date2026-08-01→2026-08-08
Completion date2026-08-01→2026-08-08
Start date2023-08-01→2023-08-08
2023-06-16
minor
Study Status v3
Primary completion date2026-06-01→2026-08-01
Completion date2026-06-01→2026-08-01
Start date2023-06-01→2023-08-01
Show 2 earlier versions
2023-05-10
minor
Study Status v2
Primary completion date2026-04-01→2026-06-01
Completion date2026-04-01→2026-06-01
Start date2023-04-01→2023-06-01
2023-02-11
minor
Study Status v1
Primary completion date2026-01-01→2026-04-01
Completion date2026-01-01→2026-04-01
Start date2023-01-01→2023-04-01
2022-11-08
minor
Original filing
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).
Trial Details
NCT Number NCT05617326
Lead Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Conditions Abdominal Aortic Aneurysm
Enrollment 400 participants
Start Date 2023-10-02
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-17