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

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

• AAA screening performed at 1 year [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 5 центров

• Cabinet IPSO Brotteaux — Lyon
• Cabinet IPSO Saint Martin — Paris
• Cabinet IPSO Nation — Paris
• Cabinet IPSO Italie — Paris
• Cabinet IPSO Ourcq — Paris

Идентификаторы

NCT: NCT05617326 · HPD_2022_8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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