Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- Freedom from reintervention
研究概览
简要总结
This is a prospective observational cohort study that will collect data from the point of referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years). The data collected will allow estimation of the success of any intervention (in terms of reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks associated with the three procedures. Clinical outcomes in the three treatment groups will be described.
Aims
We aim to answer the following questions:
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Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the risk of aneurysm growth, dissection, rupture, permanent neurological injury or death? What is the effect on quality of life (QoL)?
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If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what is the risk of growth, dissection, rupture, permanent neurological injury or death?
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How does QoL change from pre- to post intervention?
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Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?
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What is the most cost-effective strategy in:
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Patients eligible for either ESG or OSR?
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Patients eligible for either ESG or best medical therapy (BMT)?
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Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?
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What further research is required? What would be the most important research to pursue?
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thoracic Aortic Aneurysm > 4cm
- •Age ≥18 years
- •Able to give informed consent
排除标准
- •Intervention required below the level of the coeliac axis
- •Acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)
结局指标
主要结局
Freedom from reintervention
时间窗: 1, 2, 3 , 4 and 5 years post recruitment
Costs to the NHS
时间窗: 1, 2, 3 , 4 and 5 years post recruitment
Quality of life
时间窗: 1, 2, 3 , 4 and 5 years post recruitment
Incremental cost per quality adjusted life year gained
时间窗: 1, 2, 3 , 4 and 5 years post recruitment
Aneurysm Growth
时间窗: 1, 2, 3 , 4 and 5 years post recruitment
Freedom from death or permanent neurological injury
时间窗: 1, 2, 3 , 4 and 5 years post recruitment
次要结局
未报告次要终点
