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临床试验/NCT03277781
NCT03277781已完成不适用

Female Aneurysm Screening STudy

University of Leicester1 个研究点 分布在 1 个国家目标入组 5,612 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,612
试验地点
1
主要终点
Attendance

研究概览

简要总结

An abdominal aortic aneurysm (AAA) is a swelling of the main blood vessel (aorta) in the abdomen. If the swelling gets too large the aorta can burst and this is usually fatal. In order to prevent rupture, AAA can be surgically repaired. This is usually carried out when the size of the AAA is more than 5.5cm in diameter as below this size, the risk of rupture is lower than the risk of surgery. AAA are usually asymptomatic before rupture but can easily and safely be diagnosed by ultrasound scanning. There is currently a national screening programme for men, but not women.

Women are not screened for AAA on the basis that the disease is less common in females. However, 33.6% of all deaths caused by ruptured AAA in England and Wales are in females (1109 female deaths)1. Death rates due to ruptured AAA in men have nearly halved over the last decade but the reduction in female deaths over the same time period is less than one third. Females with AAA are also 4-times more likely to rupture their aneurysm and have higher rates of complications and death after emergency surgery than men.

There are groups of females such as smokers, who are at high risk of AAA. The investigators have identified risk factors that are easily identifiable from general practice databases that may be able to identify women at high risk of AAA. In this research it will be determined whether it is feasible to select women for AAA screening using these risk factors, how many women in these high-risk groups attend if they are invited for AAA screening, and screen women to determine the numbers in the different risk groups who have AAA. This will allow the assessment of whether screening women for AAA could be clinically or cost effective and who would benefit the most. The investigators will also investigate if the siblings of patients with AAAs are at higher risk of disease by inviting them for screening too.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 74 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • As per group definitions

排除标准

  • Any significant disease or disorder which, in the opinion of the Investigator or the patient's general practitioner, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

结局指标

主要结局

Attendance

时间窗: Day 1

Proportion of women attending for AAA screening

Prevalence

时间窗: Day 1

Proportion of women who attend for screening who have an AAA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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