Screening for abdominal aortic aneurysms using portable ultrasound in general practice
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
This study tests whether using portable ultrasound in regular doctor's offices can help find abdominal aortic aneurysms earlier in men aged 65 to 75 who smoke or have smoked, and in people aged 50 to 75 with a family history of the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | Male |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 5 sites (Lyon and 4 other locations) |
| Trial ID | NCT05617326 on ClinicalTrials.gov |
What this trial studies
This study aims to implement screening for abdominal aortic aneurysms (AAA) in general practice using ultraportable ultrasound technology. It targets male smokers and former smokers aged 65 to 75 years, as well as individuals aged 50 to 75 years with a family history of AAA. The screening is designed to be rapid, noninvasive, and reproducible, addressing the low access rates to recommended AAA screenings. By conducting these screenings in general practice settings, the study seeks to improve early detection and reduce mortality associated with ruptured AAAs.
Who should consider this trial
Good fit: Ideal candidates are male smokers or former smokers aged 65 to 75 years, or individuals aged 50 to 75 years with a family history of AAA.
Not a fit: Patients with a previous AAA screening within the last 5 years or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this screening approach could significantly reduce mortality rates from abdominal aortic aneurysms through earlier detection.
How similar studies have performed: Previous studies have demonstrated the effectiveness of ultrasound screening for AAA, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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)
Where this trial is running
Lyon and 4 other locations
- Cabinet IPSO Brotteaux — Lyon, France (Recruiting)
- Cabinet IPSO Saint Martin — Paris, France (Recruiting)
- Cabinet IPSO Nation — Paris, France (Recruiting)
- Cabinet IPSO Italie — Paris, France (Recruiting)
- Cabinet IPSO Ourcq — Paris, France (Recruiting)
Study contacts
- Principal investigator: Hervé Picard, MD — Hôpital Fondation A. de Rothschild
- Study coordinator: Amélie YAVCHITZ, MD
- Email: ayavchitz@for.paris
- Phone: 148036454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.