此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Computer Modeling of Congenital Heart Disease

2014年5月7日 更新者:Children's Healthcare of Atlanta
This proposal is aimed at developing a novel method for modeling and analyzing clinical factors impacting RV function, which can lead to a more reliable, consistent, and comprehensive pre-operative treatment planning. In particular, the proposed work centers on the creation of an accurate and clinically useful heart model with which to quantify, visualize, and interpret several clinical findings that are central to the medical decision-making process. The hypothesis is that by providing clinicians with 3D models that capture numerous relevant patient findings in an integrated, quantitative manner they can make more consistent, reliable, and accurate clinical assessments and may also be able to predict factors complicit in RV dysfunction and impending failure.

研究概览

地位

完全的

详细说明

The research proposed here is motivated by the need to support pediatric cardiologists in making image-based decisions in the assessment and management of congenital heart disease (CHD). In marked contrast to adult cardiology, which deals almost exclusively with the left ventricle (LV), the function of the RV is associated with a number of life-threatening conditions in pediatrics. These defects include Hypoplastic Left Heart Syndrome (HLHS), Congenitally Corrected Transposition of Great Arteries, Post operative Tetralogy of Fallot, and Double Outlet Right Ventricle.

In particular, a computer model that simulates both the myocardium and blood pool of the right ventricle (RV) is being investigated that can be used to measure clinically useful but diverse parameters of RV blood flow and wall behaviors that previously would require multiple analysis tools to acquire. The model is based on data from MRI studies of patients. Alternate measurement techniques such as ultrasound and catheter pressure measurements are needed to verify the efficacy of the model.

Through a retrospective chart review of CHD patients with defects associated with RV dysfunction, data will be obtained from CHOA over a five year period, June 1, 2001 through May 31, 2006. It will be collected from 10 children aged 0-18 years. Magnetic Resonance images, Ultrasound and catheterization measurements will be collected and analyzed.

Data from MR will be used primarily to determine RV volumetric data. This information will be used to determine RV shape at the different stages of systole and through diastole. The RV shapes are the input to the computer model. The computer model will determine relevant clinical measures such as ejection fraction, pressure measurements, strain rate, and wall thickening based solely on the MR image data. The ultrasound and catheter data will be used as independent sources of verification against the data determined from the computer model. Ultrasound data will be used to compare ejection fraction and wall behavior to the predictive model and catheter data will be used to compare pressure measurements.

研究类型

观察性的

注册 (预期的)

50

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

    • Georgia
      • Atlanta、Georgia、美国、30322
        • Children's Healthcare of Atlanta

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

不超过 18年 (孩子、成人)

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

This is a chart review of patients with heart defects associated with Right Ventricle dysfunction who have received a cardiac MRI at Children's Healthcare of Atlanta between January 1, 1990 and March 14, 2007.

描述

Inclusion Criteria:

  • Choa patients only. Data will be taken from the following patient groups:

    • Normal right ventricular (RV) EF with normal RV size and pulmonary insufficiency (PI)
    • Normal RV EF with dilated RV and PI
    • Reduced RV EF with dilated RV with PI
    • Normal RV EF (pre-operatively) dilated RV and pulmonary valve
    • replacement
    • Reduced RV EF (pre-op) dilated RV and pulmonary valve replacement

Exclusion Criteria:

  • Those who do not conform with inclusion criteria

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

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
RV Function
大体时间:1/1/1990- 3/14/2007
This proposal is aimed at developing a novel method for modeling and analyzing clinical factors impacting RV function, which can lead to a more reliable, consistent, and comprehensive pre-operative treatment planning.
1/1/1990- 3/14/2007

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。

调查人员

  • 首席研究员:Marijn E Brummer, PhD、Children's Healthcare of Atlanta

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

2001年6月1日

初级完成 (实际的)

2012年4月1日

研究完成 (实际的)

2012年4月1日

研究注册日期

首次提交

2006年8月17日

首先提交符合 QC 标准的

2006年8月17日

首次发布 (估计)

2006年8月21日

研究记录更新

最后更新发布 (估计)

2014年5月8日

上次提交的符合 QC 标准的更新

2014年5月7日

最后验证

2014年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 06-149

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.

3
订阅