跳至主要内容
临床试验/NCT05617326
NCT05617326招募中不适用

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

Fondation Ophtalmologique Adolphe de Rothschild10 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
10
主要终点
AAA screening performed at 1 year

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

AAA screening performed at 1 year

时间窗: 1 year

Percentage of included patients (eligible for AAA screening) who actually received AAA screening ultrasound within 1 year of the inclusion visit

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (10)

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