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临床试验/NCT02010892
NCT02010892Unknown不适用

Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study

Papworth Hospital NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2014年2月最近更新:
适应症

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:

  1. 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)?

  2. 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?

  3. How does QoL change from pre- to post intervention?

  4. Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?

  5. What is the most cost-effective strategy in:

  6. Patients eligible for either ESG or OSR?

  7. Patients eligible for either ESG or best medical therapy (BMT)?

  8. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?

  9. 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

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

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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