Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,010
- 试验地点
- 6
- 主要终点
- The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care
研究概览
简要总结
To determine the prevalence of Abdominal Aortic Aneurysm (AAA) in the Spanish men over 60 years through a screening program in Primary Health Care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with AAA.
详细描述
Study includes a cohort of men over 60 years attented in primary health care centers of Consorci d'Atenció Primària de Salut d'Eixample (CAPSE).General practitioners complete an ultrasonography training in an ultrasound unit under supervision of experienced radiologists using a standard ultrasound equipment and hand-held ultrasound (Trademark: VScan, Manufacturer: General Electric, USA). All images and video are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioners and radiologist. Kappa index will be used to study the agreement on the presence or absence of AAA. Multivariate logistic regression analysis will be used to determine the factors that influence the presence of AAA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 60 years or more
- •Attending at primary health care center for any complaint
排除标准
- •Subjects being hemodynamically unstable at presentation
- •Subjects with previous AAA confirmed by abdominal ultrasound scan or another image diagnosis technique
- •Subjects deemed to require emergent treatment at presentation or after initial history and physical examination.
结局指标
主要结局
The prevalence of abdominal aortic aneurysm detected by a hand-held ultrasound in Primary Care
时间窗: 12 months
次要结局
- Associated risk factors to abdominal aortic aneurysm(12 months)
研究者
Dr. Antoni Siso Almirall
Head of Research
Consorci d'Atenció Primària de Salut de l'Eixample