Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm
- Conditions
- Aortic Aneurysm, AbdominalPopliteal Artery Aneurysm
- Registration Number
- NCT05360108
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- 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 In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated.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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Abdominal aortic measurement 1 day Ultrasound of infrarenal aorta with diameter measured in mm
Popliteal artery measurement 1 day Ultrasound of popliteal artery with diameter measured in mm
- Secondary Outcome Measures
Name Time Method History of cardiovascular diseases 1 day Coronary artery disease, cerebrovascular disease, lower extremity peripheral artery disease, venous thromboembolism
Other cardiovascular risk factors 1 day Arterial hypertension, Diabetes, Dyslipidemia, Obesity
Surgical intervention for aneurysm 36 months Number of aneurysm operated during follow-up
Smoking habits 1 day Defined by active smoking, former smoking, never smoking
Family history for aneurysmal disease 1 day First-degree relatives with aneurysmal disease
Time-consuming 1 day Time needed to perform screening
Trial Locations
- Locations (2)
Centre Hospitalier Universitaire Vaudois (CHUV), Service d'Angiologie
🇨🇭Lausanne, VD, Switzerland
Ospedale di Castelfranco Veneto, UOC Angiologia
🇮🇹Castelfranco Veneto, TV, Italy