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临床试验/NCT01755936
NCT01755936已完成不适用

The Role of Myocardial Fibrosis in Patients With Aortic Stenosis

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
1
主要终点
Cardiovascular events

研究概览

简要总结

Aortic stenosis is the most common adult valvular heart disease in the western world. Heart failure and sudden cardiac death are complications associated with aortic stenosis. In symptomatic individuals, valve replacement is often the only effective treatment. However, there are no good markers to identify patients who may benefit from early surgery before symptoms developed. The purpose of the study is to test the hypothesis that the presence heart muscle scarring on the cardiac magnetic resonance imaging may predict a worse outcome in patients with aortic stenosis, and thus may be helpful in identifying patients for early valve replacement.

详细描述

Congestive heart failure and sudden cardiac death are associated complications of aortic stenosis. Currently, the indications for valvular replacement are based on the valvular severity evaluated by echocardiography and the presence of symptoms. There is some evidence to suggest the presence of myocardial fibrosis is associated with a poor outcome in patients with aortic stenosis. The aim of this prospective study is to investigate the prognostic implications of myocardial fibrosis in patients with aortic stenosis. The presence of myocardial fibrosis will be identified by delayed enhancement with the cardiac magnetic resonance imaging at 3T. We will also be evaluating the application of T1 mapping techniques to detect diffuse myocardial fibrosis.

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

  • Patients with aortic stenosis
  • Willing to undergo all investigations

排除标准

  • Coexisting mitral valvular heart disease and aortic regurgitation (more than moderate severity)
  • Active medical conditions: ongoing heart failure, infection
  • Significant comorbidities: advanced malignancy with limited life expectancy
  • Unable to give informed consent
  • Contraindication for cardiac magnetic resonance imaging: impaired renal function, pacemaker, claustrophobia

结局指标

主要结局

Cardiovascular events

时间窗: 1 year

Cardiovascular events defined as cardiovascular deaths, development of heart failure symptoms, and the need for aortic valve replacement.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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