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临床试验/NCT05360108
NCT05360108进行中(未招募)不适用

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

Centre Hospitalier Universitaire Vaudois5 个研究点 分布在 2 个国家目标入组 507 人开始时间: 2020年6月1日最近更新:
适应症

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 In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated.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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriano Alatri

MD, Senior Physician

Centre Hospitalier Universitaire Vaudois

研究点 (5)

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