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Clinical Trials/NCT05617326
NCT05617326
Recruiting
Not Applicable

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 Rothschild5 sites in 1 country400 target enrollmentOctober 2, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Aortic Aneurysm
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Enrollment
400
Locations
5
Primary Endpoint
AAA screening performed at 1 year
Status
Recruiting
Last Updated
4 months ago

Overview

Brief 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).

Registry
clinicaltrials.gov
Start Date
October 2, 2023
End Date
September 1, 2027
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

AAA screening performed at 1 year

Time Frame: 1 year

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

Study Sites (5)

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