An Investigation Into the Epidemiology and Surgical Intervention for Proximal Aortic Disease in Scotland
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,662
- 试验地点
- 1
- 主要终点
- Early survival following surgery of the proximal aorta
研究概览
简要总结
The aorta is the principal arterial vessel arising from the left heart that transfers blood to the body. Certain genetic and familial disease processes are known to weaken the aortic wall resulting in dilation and potential rupture. These aortic complications carry high mortality (>25%) and current management is orientated towards early detection and preventive treatment. Aortic dilation can also result in aortic valve dysfunction leading to heart failure. The estimated UK incidence of aortic disease per year is around 10 per 100,000 individuals, with 2000 people per year dying from aortic complications.
The 2017-2020 National Adult Cardiac Surgery Audit report identified the number of people receiving surgery for aortic dissection in Scotland is per population proportionately lower compared to England (4.6 per million per year in Scotland vs. 6.6 per million per year in England). The reasons for this are unclear but may relate to the prevalence of aortic disease or a large geographic distribution with compromised access to specialized centres.
Currently surgery is recommended when the aortic diameter exceeds a certain threshold. There are several types of effective surgical procedures, but there is still limited information on their long-term outcomes and the advantage of one procedure over another.
The aims of the project are firstly to determine the clinical outcomes of the surgical procedures that are currently employed in Scotland to treat proximal aortic disease and secondly to describe the prevalence and distribution of proximal aortic disease within the Scottish population. The project will be hosted by the Golden Jubilee Research Institute. Contemporary and retrospective data will be collected from all the Scottish Cardiothoracic Surgery units which are based in Glasgow, Edinburgh and Aberdeen.
This will be the first study to analyse surgical outcomes for ascending aortic disease in Scotland, and the first to describe the epidemiology of aortic disease within the population. It is anticipated that the results will guide current surgical practise, and provide data to inform national service provision for the management of proximal aortic disease.
详细描述
The study has two principal aims:
- Determine the patient demographics, procedural types and related clinical outcomes in patients who underwent surgery of the proximal thoracic aorta in Scotland
- Describe the epidemiology of proximal aortopathy within the Scottish population, by determining the prevalence of disease, geographic distribution and patient demographics
This study will be the first to look at outcomes from a nation-wide cohort of patients following surgery of the thoracic aorta in the UK. The investigators anticipate that results from this study will inform future aortic practice and guide decisions on intervention timing and type.
Information on the prevalence and geographic distribution of aortic disease within Scotland will guide resource allocation and service configuration to allow equity in access to treatment. By raising awareness among the medical professionals and the wider community, the study should lead to improved recognition and better outcomes for patients with aortic disease.
Data will be recorded in a contemporary and retrospective manner for two patient cohorts:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •all adults (>18 years of age) that underwent surgical intervention on the proximal aorta in Scotland between 2008 and 2021.
排除标准
- •Isolated surgery on the descending thoracic aorta
- •Non-surgical cohort
- •Inclusion Criteria:
- •all adult patients (>18 years of age) with a radiological, genetic or post-mortem diagnosis of thoracic aortic disease
结局指标
主要结局
Early survival following surgery of the proximal aorta
时间窗: In-hospital or 30 days (whichever is longer)
In-hospital or 30 days survival following surgery of the proximal aorta
Late survival following surgery of the proximal aorta
时间窗: 5 years or latest available follow-up (whichever is longer)
Long-term survival following surgery of the proximal aorta
Patient demographics and geographic distribution of thoracic aortopathy within the Scottish population
时间窗: Cross-sectional analysis (2011-2021)
Identify the demographics (age, gender, relevant risk factors) and geographic distribution (area codes) of patients diagnosed with thoracic aortopathy within the Scottish population
次要结局
- Specified adverse events following surgery(1 year or latest available follow-up (whichever is longer))
- Cardiovascular reintervention(1 year or latest available follow-up (whichever is longer))
- Left ventricular ejection fraction (LVEF) following surgery(1 year or latest available follow-up (whichever is longer))
- Aortic valve mean gradient and degree of regurgitation following surgery(1 year or latest available follow-up (whichever is longer))
- Genotypes and phenotypes prevalent in the Scottish population(Previous 5 years)
研究者
George Gradinariu
Principal Investigator, Cardiothoracic Surgery Specialty Registrar
Golden Jubilee National Hospital