Informations générales (source: ClinicalTrials.gov)
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 (DACEP)
Interventional
N/A
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
octobre 2023
octobre 2025
05 décembre 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Amélie Yavchitz | 21/06/2024 13:34:49 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Cabinet IPSO Italie - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
| Cabinet IPSO Nation - 75011 - Paris - France | Contact (sur clinicalTrials) | ||||
| Cabinet IPSO Ourcq - 75019 - Paris - France | BERNARD Laurène | Contact (sur clinicalTrials) | |||
| Cabinet IPSO Saint Martin - 75003 - Paris - France | PICARD HERVE | Contact (sur clinicalTrials) | |||
Critères
Homme
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
- 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
- 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)