DAAP-PR: Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm

Sponsor
Centre Hospitalier Universitaire Vaudois (Other)
Overall Status
Recruiting
CT.gov ID
NCT05360108
Collaborator
(none)
1,000
2
82
500
6.1

Study Details

Study Description

Brief Summary

Observational, prospective, cohort study to evaluate, by an opportunistic screening program based on vascular ultrasound, the prevalence and characteristics of Abdominal Aortic Aneurysm (AAA) and Popliteal Artery Aneurysm (PAA) in a female population as well as the prevalence and characteristics of PAA in male population.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Abdominal aortic aneurysm (AAA) remains a highly topical issue given the potentially dramatic consequences associated with its rupture. In men, the prevalence of AAA is declining, probably due to improved management of risk factors. However, the most recent studies and international recommendations have reaffirmed that screening for AAA in men is still important and cost-effective. In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated. For this reason, the recommendations are contrasting and not univocal. About 35% of patients with AAA have a second aneurysm more distally. Popliteal artery aneurysm (PAA) is the most common. Like AAA, PAA is often asymptomatic and its main complication is thrombotic occlusion resulting in acute/chronic ischemia of the affected limb and a high prevalence of permanent sequelae (mainly amputation). Data on epidemiology and risk factors of PAA are very limited in men and absent in women. In addition, the benefit of PAA screening has never been assessed so far.

    The aim of this study is to evaluate, by an opportunistic screening program based on vascular ultrasound, the prevalence and characteristics of AAA and PAA in a female population as well as the prevalence and characteristics of PAA in male population. The project represents the first screening program for popliteal aneurysm. Finally, the results will allow us to better assess need for and modalities of a screening program.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm in At-risk Population (DAAP-PR Study)
    Actual Study Start Date :
    Feb 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Abdominal aortic measurement [1 day]

      Ultrasound of infrarenal aorta with diameter measured in mm

    2. Popliteal artery measurement [1 day]

      Ultrasound of popliteal artery with diameter measured in mm

    Secondary Outcome Measures

    1. Smoking habits [1 day]

      Defined by active smoking, former smoking, never smoking

    2. Other cardiovascular risk factors [1 day]

      Arterial hypertension, Diabetes, Dyslipidemia, Obesity

    3. History of cardiovascular diseases [1 day]

      Coronary artery disease, cerebrovascular disease, lower extremity peripheral artery disease, venous thromboembolism

    4. Family history for aneurysmal disease [1 day]

      First-degree relatives with aneurysmal disease

    5. Time-consuming [1 day]

      Time needed to perform screening

    6. Surgical intervention for aneurysm [36 months]

      Number of aneurysm operated during follow-up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Women aged ≥65 years who are current smokers

    • Men aged ≥65 years

    • Women or Men aged ≥55 years with family history (first-degree relatives) for Abdominal Aortic Aneurysm (AAA) or popliteal artery aneurysm (PAA)

    Exclusion Criteria:
    • Patient with known diagnosis of AAA or PAA

    • Patient already operated for AAA or PAA

    • AAA/PAA screening or arterial assessment of lower limbs within the last 12 months

    • Inability to understand and/or sign study consent

    • Inability to access follow-up controls

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ospedale di Castelfranco Veneto, UOC Angiologia Castelfranco Veneto TV Italy I-31033
    2 Centre Hospitalier Universitaire Vaudois (CHUV), Service d'Angiologie Lausanne VD Switzerland 1011

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Vaudois

    Investigators

    • Study Chair: Lucia Mazzolai, MD, PhD, Centre Hospitalier Universitaire Vaudois
    • Principal Investigator: Adriano Alatri, MD, Centre Hospitalier Universitaire Vaudois

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Adriano Alatri, MD, Senior Physician, Centre Hospitalier Universitaire Vaudois
    ClinicalTrials.gov Identifier:
    NCT05360108
    Other Study ID Numbers:
    • DAAP-PR study
    First Posted:
    May 4, 2022
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Adriano Alatri, MD, Senior Physician, Centre Hospitalier Universitaire Vaudois
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2022