Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm in At-risk Population (DAAP-PR Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 507
- 试验地点
- 5
- 主要终点
- Abdominal aortic measurement
研究概览
简要总结
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.
详细描述
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 In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated.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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Abdominal aortic measurement
时间窗: 1 day
Ultrasound of infrarenal aorta with diameter measured in mm
Popliteal artery measurement
时间窗: 1 day
Ultrasound of popliteal artery with diameter measured in mm
次要结局
- Other cardiovascular risk factors(1 day)
- Surgical intervention for aneurysm(36 months)
- Smoking habits(1 day)
- Family history for aneurysmal disease(1 day)
- Time-consuming(1 day)
- History of cardiovascular diseases(1 day)
研究者
Adriano Alatri
MD, Senior Physician
Centre Hospitalier Universitaire Vaudois
