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临床试验/NCT04756778
NCT04756778已完成不适用

Relationship Between Indexed Aortic Area and Aortic Diameter in Bicuspid Aortic Valve Aortopathy: A Retrospective Cohort Study

St. George's Hospital, London1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2017年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
69
试验地点
1
主要终点
Cross-sectional aortic area/patient height ratio in aneurysms

研究概览

简要总结

This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve. This will shed light on whether aneurysms with smaller diameters than those recommended for surgical intervention by guidelines are still at risk of aortic complications attending an abnormally high indexed aortic area.

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

入选标准

  • Age >18 years
  • First-time surgery
  • Bicuspid aortic valve confirmed
  • Thoracic aortic aneurysm involving aortic root or ascending aorta

排除标准

  • No available pre-operative cross-sectional imaging
  • Re-do surgery

结局指标

主要结局

Cross-sectional aortic area/patient height ratio in aneurysms

时间窗: Data collection period from 27th January 2017 - 15th May 2017

Calculation of indexed aortic area in aneurysms

Median cross-sectional aortic area/patient height ratio for aneurysms with diameter <4.0 cm, 4.0-4.5 cm, 4.5-5.0 cm, 5.0-5.5 cm and >5.5 cm

时间窗: Data collection period from 27th January 2017 - 15th May 2017

Median aortic diameters in aneurysms

时间窗: Data collection period from 27th January 2017 - 15th May 2017

As above

Median aortic diameter corresponding to aneurysms with IAA >10 cm2/m

时间窗: Data collection period from 27th January 2017 - 15th May 2017

Proportion of aneurysms with cross-sectional aortic area/patient height ratio >10 cm2/m

时间窗: Data collection period from 27th January 2017 - 15th May 2017

Proportion of aneurysms with an abnormal indexed aortic area

次要结局

未报告次要终点

研究者

发起方
St. George's Hospital, London
申办方类型
Other
责任方
Principal Investigator
主要研究者

Metesh Acharya

Mr Metesh Acharya

St. George's Hospital, London

研究点 (1)

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