Greenwood John P, Maredia Neil, Radjenovic Aleksandra, Brown Julia M, Nixon Jane, Farrin Amanda J, Dickinson Catherine, Younger John F, Ridgway John P, Sculpher Mark, Ball Stephen G, Plein Sven
Division of Cardiovascular and Neuronal Remodelling, Leeds Institute of Genetics, Health and Therapeutics, University of Leeds, Leeds General Infirmary, Leeds, LS1 3EX, UK.
Trials. 2009 Jul 29;10:62. doi: 10.1186/1745-6215-10-62.
Several investigations are currently available to establish the diagnosis of coronary heart disease (CHD). Of these, cardiovascular magnetic resonance (CMR) offers the greatest information from a single test, allowing the assessment of myocardial function, perfusion, viability and coronary artery anatomy. However, data from large scale studies that prospectively evaluate the diagnostic accuracy of multi-parametric CMR for the detection of CHD in unselected populations are lacking, and there are few data on the performance of CMR compared with current diagnostic tests, its prognostic value and cost-effectiveness.
METHODS/DESIGN: This is a prospective diagnostic accuracy cohort study of 750 patients referred to a cardiologist with suspected CHD. Exercise tolerance testing (ETT) will be preformed if patients are physically able. Recruited patients will then undergo CMR and single photon emission tomography (SPECT) followed in all patients by invasive X-ray coronary angiography. The order of the CMR and SPECT tests will be randomised. The CMR study will comprise rest and adenosine stress perfusion, cine imaging, late gadolinium enhancement and whole-heart MR coronary angiography. SPECT will use a gated stress/rest protocol. The primary objective of the study is to determine the diagnostic accuracy of CMR in detecting significant coronary stenosis, as defined by X-ray coronary angiography. Secondary objectives include an assessment of the prognostic value of CMR imaging, a comparison of its diagnostic accuracy against SPECT and ETT, and an assessment of cost-effectiveness.
The CE-MARC study is a prospective, diagnostic accuracy cohort study of 750 patients assessing the performance of a multi-parametric CMR study in detecting CHD using invasive X-ray coronary angiography as the reference standard and comparing it with ETT and SPECT.
Current Controlled Trials ISRCTN77246133.
目前有多种检查可用于冠心病（CHD）的诊断。其中，心血管磁共振成像（CMR）单次检查提供的信息最多，可评估心肌功能、灌注、存活心肌及冠状动脉解剖结构。然而，缺乏大规模前瞻性评估多参数CMR在未选择人群中检测CHD诊断准确性的研究数据，与当前诊断检查相比，CMR的性能、预后价值及成本效益方面的数据也很少。
方法/设计：这是一项对750例疑似CHD并转诊至心脏病专家处的患者进行的前瞻性诊断准确性队列研究。若患者身体状况允许，将进行运动耐量测试（ETT）。招募的患者随后将接受CMR和单光子发射断层扫描（SPECT）检查，所有患者之后均接受有创X线冠状动脉造影。CMR和SPECT检查的顺序将随机安排。CMR研究将包括静息和腺苷负荷灌注、电影成像、延迟钆增强及全心磁共振冠状动脉造影。SPECT将采用门控负荷/静息方案。该研究的主要目的是确定CMR检测由X线冠状动脉造影定义的显著冠状动脉狭窄的诊断准确性。次要目的包括评估CMR成像的预后价值，将其诊断准确性与SPECT和ETT进行比较，以及评估成本效益。
CE-MARC研究是一项对750例患者进行的前瞻性诊断准确性队列研究，以有创X线冠状动脉造影作为参考标准，评估多参数CMR研究在检测CHD方面的性能，并将其与ETT和SPECT进行比较。
当前受控试验ISRCTN77246133。
