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Active, Not Recruiting

NCT Number: NCT05360108

Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale di Castelfranco Veneto, AULSS 2 Marca Trevigiana, Via dei Carpani 16/Z, Castelfranco Veneto, TV, Italy

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About this study

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 In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Abdominal aortic measurement

    Time frame: 1 day

    Ultrasound of infrarenal aorta with diameter measured in mm

  2. Popliteal artery measurement

    Time frame: 1 day

    Ultrasound of popliteal artery with diameter measured in mm

Secondary outcomes

  1. Smoking habits

    Time frame: 1 day

    Defined by active smoking, former smoking, never smoking

  2. Other cardiovascular risk factors

    Time frame: 1 day

    Arterial hypertension, Diabetes, Dyslipidemia, Obesity

  3. History of cardiovascular diseases

    Time frame: 1 day

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

  4. Family history for aneurysmal disease

    Time frame: 1 day

    First-degree relatives with aneurysmal disease

  5. Time-consuming

    Time frame: 1 day

    Time needed to perform screening

  6. Surgical intervention for aneurysm

    Time frame: 36 months

    Number of aneurysm operated during follow-up

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm in At-risk Population (DAAP-PR Study)

Acronym: DAAP-PR

Important dates

Study start
2020
Primary completion
2026
Study completion
2029
First posted
May 4, 2022
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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