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

Primary Purpose

Abdominal Aortic Aneurysm

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AAA screening by a GP
AAA screening by a radiologist
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Abdominal Aortic Aneurysm

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    screening by a GP

    screening by a radiologist (conventional)

    Arm Description

    Each patient in this group will have a screening for AAA performed by a trained general practitioner

    Each patient in this group will have AAA screening performed by a radiologist

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 8, 2022
    Last Updated
    July 27, 2023
    Sponsor
    Fondation Ophtalmologique Adolphe de Rothschild
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05617326
    Brief Title
    Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound
    Acronym
    DACEP
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 8, 2023 (Anticipated)
    Primary Completion Date
    August 8, 2026 (Anticipated)
    Study Completion Date
    August 8, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondation Ophtalmologique Adolphe de Rothschild

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Aortic Aneurysm

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    screening by a GP
    Arm Type
    Experimental
    Arm Description
    Each patient in this group will have a screening for AAA performed by a trained general practitioner
    Arm Title
    screening by a radiologist (conventional)
    Arm Type
    Other
    Arm Description
    Each patient in this group will have AAA screening performed by a radiologist
    Intervention Type
    Other
    Intervention Name(s)
    AAA screening by a GP
    Intervention Description
    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..
    Intervention Type
    Other
    Intervention Name(s)
    AAA screening by a radiologist
    Intervention Description
    General practitioners in the control group will refer their patients to the radiologist for AAA screening.
    Primary Outcome Measure Information:
    Title
    AAA screening performed at 1 year
    Description
    Percentage of included patients (eligible for AAA screening) who actually received AAA screening ultrasound within 1 year of the inclusion visit
    Time Frame
    1 year

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amélie YAVCHITZ, MD
    Phone
    148036454
    Ext
    +33
    Email
    ayavchitz@for.paris
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hervé Picard, MD
    Organizational Affiliation
    Hôpital Fondation A. de Rothschild
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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