Clinical trial NCT05360108: Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm
Official title: Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm in At-risk Population (DAAP-PR Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Aneurysm, Abdominal
Popliteal Artery Aneurysm
Keywords: Abdominal aortic aneurysm
Popliteal aneurysm
Screening
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women or Men at high risk for aneurysmal disease

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 In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated.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

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

Primary outcomes:
measure: Abdominal aortic measurement
timeFrame: 1 day
measure: Popliteal artery measurement
timeFrame: 1 day
Secondary outcomes:
measure: Smoking habits
timeFrame: 1 day
measure: Other cardiovascular risk factors
timeFrame: 1 day
measure: History of cardiovascular diseases
timeFrame: 1 day
measure: Family history for aneurysmal disease
timeFrame: 1 day
measure: Time-consuming
timeFrame: 1 day
measure: Surgical intervention for aneurysm
timeFrame: 36 months
Other outcomes:
Locations:
city: Castelfranco Veneto
country: Italy
facility: Ospedale di Castelfranco Veneto, UOC Angiologia
state: TV
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV), Service d'Angiologie
state: VD
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Lucia Mazzolai, MD, PhD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire Vaudois
name: Adriano Alatri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Svensjo S, Mani K, Bjorck M, Lundkvist J, Wanhainen A. Screening for abdominal aortic aneurysm in 65-year-old men remains cost-effective with contemporary epidemiology and management. Eur J Vasc Endovasc Surg. 2014 Apr;47(4):357-65. doi: 10.1016/j.ejvs.2013.12.023. Epub 2014 Jan 31.
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citation: Aboyans V, Bataille V, Bliscaux P, Ederhy S, Filliol D, Honton B, Kurtz B, Messas E, Mohty D, Brochet E, Kownator S; investigators of the E2T3A study. Effectiveness of screening for abdominal aortic aneurysm during echocardiography. Am J Cardiol. 2014 Oct 1;114(7):1100-4. doi: 10.1016/j.amjcard.2014.07.024. Epub 2014 Jul 18.
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