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MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery (MRI-MVS)

2018年1月9日 更新者:Atlantic Health System

Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study

Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.

研究概览

地位

未知

详细说明

Mitral regurgitation is a common disease which can lead to heart failure and death if left untreated. The only known therapy for mitral regurgitation is correction of the mitral valve, most commonly performed by surgical repair or replacement. According the STS database, there were 15,748 lone mitral valve surgeries in 2014. The number of mitral valve surgeries has been increasing with a 23% increase between the years 2010 and 2014. Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the severity of mitral regurgitation is central to determining which patients are appropriate for correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made, patients are considered appropriate for mitral valve surgery in almost all clinical circumstances. However, there is a significant mortality and morbidity associated with mitral valve surgery. In the STS database, 30 day mortality was ~2% for repair and ~5% for replacement. This data does not take into account long-term mortality and morbidity from re-operation and life-long anti-coagulation as well as changes in quality of life.

The most common diagnostic tool to assess the severity of MR is echocardiography. Several studies have shown that echocardiography parameters used to quantify and qualify MR have high inter-observer and intra-observer variability, calling the accuracy of these parameters into question. Furthermore, studies have shown that there is a significant degree of discordance between echocardiography and MRI when assessing MR, particularly among patients referred for mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was found to be more accurate than echocardiography in patients who underwent mitral valve surgery. All 38 patients who underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA guidelines based on echocardiographic findings. However, more than 2/3rds of patients who underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs. repair according to MR severity by MRI.

研究类型

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Subjects who are scheduled to undergo ACC/AHA guideline directed mitral valve surgery for mitral regurgitation.

描述

Inclusion Criteria:

  • Age 18 years and older.
  • Able to give informed consent.
  • Undergoing lone mitral valve surgery for chronic primary mitral regurgitation within 30 days.
  • Indication for mitral valve surgery is a class I or IIa according to the 2014 ACC/AHA guidelines for the management of valvular heart disease.

Exclusion Criteria:

  • Secondary mitral regurgitation.
  • Have a device which is not compatible with MRI
  • Claustrophobia preventing MRI.
  • Concomitant CABG, other valve surgery, or other cardiac surgery.
  • Atrial fibrillation or other substantial arrhythmia that would substantially degrade MRI image acquisition.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Mitral Valve Surgery
Patients undergoing ACC/AHA guideline directed mitral valve surgery for mitral insufficiency.
ACC/AHA guideline directed mitral valve repair or replacement

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Operative and peri-operative outcomes according to the mitral regurgitation severity quantified by MRI.
大体时间:2 years
Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.
2 years

次要结果测量

结果测量
措施说明
大体时间
Quality of life
大体时间:2 years
Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.
2 years
Repair vs Replacement
大体时间:4 months
Assess if the likelihood of mitral valve repair vs. replacement is associated with mitral regurgitant severity as quantified by MRI.
4 months
Severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery.
大体时间:0 days
Cross sectional data regarding severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery
0 days
Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.
大体时间:4 months
Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.
4 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2017年1月1日

初级完成 (预期的)

2020年12月1日

研究完成 (预期的)

2020年12月1日

研究注册日期

首次提交

2016年12月16日

首先提交符合 QC 标准的

2017年1月4日

首次发布 (估计)

2017年1月6日

研究记录更新

最后更新发布 (实际的)

2018年1月11日

上次提交的符合 QC 标准的更新

2018年1月9日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Mitral valve surgery的临床试验

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