跳至主要内容
临床试验/NCT00857792
NCT00857792已完成不适用

Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging

University of Chicago1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT.

研究概览

简要总结

The investigators goals are:

  1. to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images
  2. to test its ability to accurately determine the presence, location, extend and severity of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns
  3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.

详细描述

Background

Multidetector computed tomography (MDCT) is the most recent addition to the arsenal of cardiac imaging modalities. With its unparalleled spatial resolution and well established techniques for contrast enhancement using conventional iodine-based agents, it allows visualization of coronary arteries and is thus increasingly used as an alternative to invasive coronary angiography (ICA) (de Roos A. et al. 07,Deetjen et al. 07,Schroeder et al. 08). The diagnostic value of noninvasive coronary angiography (CTCA) has been established against conventional techniques used for the diagnosis and evaluation of coronary artery disease (CAD), including ICA (Budoff et al. 07,Leber et al. 05,Raff et al. 05,Rubinshtein et al. 07) and SPECT myocardial perfusion imaging (MPI) (Hacker et al. 07,Rubinshtein et al. 07,Schuijf et al. 06). Nevertheless, the physiological significance of intermediate grade stenosis detected by CTCA in individual patients is unknown and such patients are routinely referred for stress testing in order to define individual therapeutic strategy. It has been suggested that intramyocardial distribution of contrast during the arterial phase of enhancement may be related to myocardial perfusion (Cury et al. 07). Several studies have demonstrated hypo-enhanced areas corresponding to myocardial scar tissue in a small number of patients post myocardial infarction (MI) (Gerber et al. 06,Henneman et al. 06,Mahnken et al. 05,Nieman et al. 06,Nikolaou et al. 05), and in animal models of acute MI (George et al. 07,Gerber et al. 06,Hoffmann et al. 04,Lardo et al. 06). Our hypothesis is that perfusion information, which can be extracted from images acquired for CTCA without additional radiation exposure or contrast load, could be a useful addition to the MDCT evaluation of ischemic heart disease (IHD).

Accordingly, we recently completed a study designed to determine the value of MDCT assessment of resting myocardial perfusion in consecutive patients referred to CTCA. In this study, we developed and tested a new technique for quantitative assessment of myocardial perfusion based on analysis of MDCT images acquired for CTCA. The accuracy of resting MDCT perfusion was tested against ICA as well as MPI. Both protocols included a detailed investigation of the sources of inter-technique discordance.

Comparisons against ICA revealed that the majority of perfusion abnormalities detected on MDCT images at rest were associated with either prior MI, as previously reported (Gerber et al. 06,Henneman et al. 06,Mahnken et al. 05,Nieman et al. 06,Nikolaou et al. 05), or reduced blood supply secondary to significant stenosis. This previously unknown finding may have important clinical implications in the context of detection of myocardial ischemia. Although comparisons against resting MPI data showed high levels of agreement, we noted a large number of perfusion defects that were not confirmed by resting MPI. These apparent "false positive" findings were found to be either directly related to suboptimal image quality or were true positives when compared to stress MPI. This latter surprising finding may probably be explained by the effects of nitroglycerin used during MDCT imaging, as well as possible vasodilating effects of the iodine-based contrast media (Limbruno et al. 00), which may to some extent mimic those of vasodilator stress agents used during MPI, namely adenosine or dipyridamole.

The main conclusion of these recent studies was that future studies are needed to explore the full diagnostic potential of MDCT perfusion when used in combination with vasodilator stress.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • 18 years and older
  • Subjects referred for clinically indicated cardiac CT exams

排除标准

  • Subjects with a history of lung disease
  • Pregnant subjects
  • Subjects with second or third degree AV block or sinus node dysfunction

研究组 & 干预措施

Open Label

Other

干预措施: regadenoson (Drug)

结局指标

主要结局

Ability to Detect Stress-induced Myocardial Perfusion Abnormalities by Analysis of MDCT Images Confirmed by Coronary Angiography and/or SPECT.

时间窗: 3 months

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)

Loading locations...

相似试验