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临床试验/NCT01905852
NCT01905852撤回不适用

Utilization of Cardiac Magnetic Resonance Imaging to Predict Clinical Outcomes of Patients With Severe Aortic Stenosis

National Heart, Lung, and Blood Institute (NHLBI)0 个研究点开始时间: 2013年6月27日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
To assess the ability of cardiac MRI measurement of extracellular volume fraction (related to myocardial fibrosis) to predict short and long term LV function of subjects with severe aortic stenosis undergoing transcatheter AVR.

研究概览

简要总结

Background:

  • Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of ways, including replacing a heart valve.

Objectives:

Researchers want to study fibrosis in the heart. A sub-study will test whether heart function and blood supply improve after a valve replacement.

Eligibility:

  • Adults at least 18 years old with aortic stenosis.

Design:

  • Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of their heart. This uses magnets, radio waves, and computers to produce detailed pictures of the heart.
  • After this visit, participants will have their aortic valve procedure at the the Washington Hospital Center. A hospital team will contact participants for 1 year by phone or email. This follow-up will consist of 15 minutes of questions about the participant s health status.
  • Some participants will join a sub-study.
  • They will be given an additional medication to evaluate the blood supply of the heart.
  • They will visit a clinic for 1 day for an MRI of their heart, as part of the main study, prior to the aortic valve replacement.
  • After they have their valve replaced at the hospital, they will return to the clinic for another MRI.
  • They will have the same follow-up as in the main study.

详细描述

Aortic valve stenosis is a disease that causes narrowing of a major heart valve, and that reduces heart function and causes death. The purpose of this protocol is to use magnetic resonance imaging of the heart to identify which patients would benefit from replacement of the diseased valve.

研究设计

研究类型
Observational
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To assess the ability of cardiac MRI measurement of extracellular volume fraction (related to myocardial fibrosis) to predict short and long term LV function of subjects with severe aortic stenosis undergoing transcatheter AVR.

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

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