Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm

NCT ID: NCT05360108

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2028-06-30

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.

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 In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated.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

Conditions

Aortic Aneurysm, Abdominal; Popliteal Artery Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Adriano Alatri

MD, Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucia Mazzolai, MD, PhD

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Vaudois

Adriano Alatri, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

Ospedale di Castelfranco Veneto, UOC Angiologia

Castelfranco Veneto, TV, Italy

Site Status: RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV), Service d'Angiologie

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Italy; Switzerland

Central Contacts

Adriano Alatri, MD

Role: CONTACT

adriano.alatri@chuv.ch

+41795565725

Lucia Mazzolai, MD, PhD

Role: CONTACT

lucia.mazzolai@chuv.ch

+41795565661

Facility Contacts

Adriana Visonà, MD

Role: primary

adriana.visona@aulss2.veneto.it

Paola Bigolin, MD

Role: backup

paola.bigolin@aulss2.veneto.it

Adriano Alatri, MD

Role: primary

adriano.alatri@chuv.ch

+41795565725

Lucia Mazzolai, MD, PhD

Role: backup

lucia.mazzolai@chuv.ch

+41795565661

References

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Reference Type: BACKGROUND

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Other Identifiers

DAAP-PR study

Identifier Type: -

Identifier Source: org_study_id