Abdominal Aortic AneurysmDACEPNCT05617326
Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound
A study testing AAA screening by a GP and AAA screening by a radiologist in people with Abdominal Aortic Aneurysm, run by Fondation Ophtalmologique Adolphe de Rothschild at 6 sites in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- AAA screening by a GP and AAA screening by a radiologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 6 sitesFrance
- Study dates
- 2 Oct 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Cabinet IPSO Brotteaux
Lyon, 69006
Adrien NAEGELEN, Dr, +33428290929, adrien.naegelen@ipsosante.fr
- Recruiting
Cabinet IPSO Saint Martin
Paris, 75003
Hervé PICARD, Dr, 01 84 20 20 20, herve.picard@ipso.paris
- Recruiting
Cabinet IPSO Nation
Paris, 75011
Inès DUMORTIER, Dr, +33180407777, ines.dumortier@ipsosante.fr
- Recruiting
Cabinet IPSO Richard-Lenoir
Paris, 75011
Valentin GONZALEZ, Dr, 06 31 50 12 56, valentin.gonzalez@ipsosante.fr
- Recruiting
Cabinet IPSO Italie
Paris, 75013
Roxane LIARD, Dr, 01 84 20 20 15, roxane.liard@ipsosante.fr
- Recruiting
Cabinet IPSO Ourcq
Paris, 75019
Laurène BERNARD, Dr, laurene.bernard@ipsosante.fr
About this study
Official title: 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
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).
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- AAA screening by a GP, AAA screening by a radiologist
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAA screening by a GPOther
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..
AAA screening by a radiologistOther
General practitioners in the control group will refer their patients to the radiologist for AAA screening.
| Study group | Role | What they receive |
|---|---|---|
| screening by a GP | Experimental | Each patient in this group will have a screening for AAA performed by a trained general practitioner Receives: Other: AAA screening by a GP |
| screening by a radiologist (conventional) | Other | Each patient in this group will have AAA screening performed by a radiologist Receives: Other: AAA screening by a radiologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
AAA screening performed at 1 year
Percentage of included patients (eligible for AAA screening) who actually received AAA screening ultrasound within 1 year of the inclusion visit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start2 Oct 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hervé Picard, MD, Principal investigator, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617326
- Sponsor's protocol ID
- HPD_2022_8
- Acronym
- DACEP
- Status last verified
- Oct 2026
- First submitted
- 8 Nov 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05617326
- Acronym / sponsor ID
- DACEP / HPD_2022_8
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screening by a GP | Experimental | Other: AAA screening by a GPEach patient in this group will have a screening for AAA performed by a trained general practitioner |
| screening by a radiologist (conventional) | Other | Other: AAA screening by a radiologistEach patient in this group will have AAA screening performed by a radiologist |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAA screening by a GPThe 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.. | Other | screening by a GP |
| AAA screening by a radiologistGeneral practitioners in the control group will refer their patients to the radiologist for AAA screening. | Other | screening by a radiologist (conventional) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hervé Picard, MD principal investigator
Hôpital Fondation A. de Rothschild
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAA screening by a GP and AAA screening by a radiologist in people with Abdominal Aortic Aneurysm, run by Fondation Ophtalmologique Adolphe de Rothschild at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie YAVCHITZ, MD (148036454 ext. +33, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AAA screening performed at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.