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临床试验/NCT01205945
NCT01205945Unknown不适用

The Effect of Abdominal Aortic Aneurysm Screening on Mortality in Asian: A Randomized, Controlled Trial

Kyunghee University Medical Center1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
12,000
试验地点
1

研究概览

简要总结

Abdominal aortic aneurysm(AAA) occurs when the infrarenal aorta expands to a maximal diameter of 3.0cm or greater. Although AAA may asymptomatic for many years, almost one third eventually rupture if left untreated.

Several randomized trials showed that ultrasonographic screening for AAA could reduce the frequency of acute operations and AAA-related mortality.

However, all of randomized trials were performed in Western countries. There was no randomized trials for AAA screening in Asian countries.

This randomized, controlled trial is to analyze the benefits of screening old population for AAA in Korea.

详细描述

Old population, aged from 60 to 85 years, are randomized into two groups; one group is invited for ultrasonographic screening for AAA, and the other acts as age- and sex-matched controls.

For screening group, The anterioposterior and transverse diameter of the infrarenal aorta is measured at their maximal sizes. The subsequent surveillance of screened patients is done as follows

  • Aortic diameter less than 3.0cm, no further testing
  • AAA 3 to 4cm, ultrasonographic follow-up every year
  • AAA 4 to 5cm, ultrasonographic follow-up every 6 months
  • AAA greater than 5cm, referral to a vascular surgeon

For control group, the information for any causes of death is collected every year.

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
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all men aged 60 to 85 years
  • women aged 60 to 85 years with cardiovascular risk factors such as hypertension, hyperlipidemia, peripheral arterial occlusive disease, coronary artery disease, cerebrovascular attack.
  • men and women older than 50 years with a family history of AAA

排除标准

  • people who was diagnosed with AAA
  • people who underwent aneurysm repair such as open aneurysm repair or endovascular aneurysm repair
  • People who underwent abdominal aortic surgery such as aortobifemoral bypass
  • People whose life expectancy is less than 2 years
  • People who appear unfit for repair of AAA
  • people who do not agree with this study

研究者

申办方类型
Other

研究点 (1)

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