Clinical Trial

Proximal Aortopathy in Scotland - Epidemiology and Surgical Outcomes

Unknown
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Record status
This record was last updated July 15, 2024 (before its estimated August 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT05389865
Lead Sponsor Golden Jubilee National Hospital
Collaborators: Aberdeen Royal Infirmary, Royal Infirmary of Edinburgh, Network for Inherited Cardiac Conditions Scotland, University of Glasgow
Conditions Aortic Diseases, Aortic Dissection, Aortic Aneurysm, Thoracic, Aortic Ectasia, Aortic Valve Insufficiency, Bicuspid Aortic Valve, Marfan Syndrome, Ehlers-Danlos Syndrome +1 more
Enrollment 1,662 participants
Start Date 2023-12-18
Primary Completion 2025-08 (estimated)
Study Completion 2025-08 (estimated)
Updated on ClinicalTrials.gov 2024-07-15