Rule-Out Myocardial Infarction Using Computed Assisted Tomography-ROMICATII,DCC

描述(由申请人提供)： 本申请代表整个提案的临床协调中心。急性胸痛和正常或非诊断性心电图(ECG)的患者代表了一个队列，他们的管理明显效率低下，在诊断上具有挑战性。在急诊科(ED)的初始评估中，医生通常不能通过典型的诊断测试(如核成像、超声心动图和运动平板心电)排除心肌缺血的发生，这些患者大多住院24至36小时以排除急性冠脉综合征(ACS)的存在。在美国每年收治的600万急性胸痛患者中，有10%最终被诊断为急性冠脉综合征。此外，负面评估的住院护理每年造成超过80亿美元的经济负担。心脏计算机断层扫描(CT)技术的最新进展使冠状动脉粥样硬化斑块和狭窄的准确检测成为可能，也使医生能够评估整体和局部的左心室功能。盲法观察研究表明，心脏CT检测到的冠状动脉粥样硬化斑块的缺失是没有ACS的一个强有力的预测因子(阴性预测值[NPV]为100%)。因此，在早期急诊分诊过程中实施心脏CT可以使相当一部分急性胸痛患者立即安全出院，而不需要进一步的测试。然而，同样重要的是要确定心脏CT对住院患者管理的影响，特别是住院时间、有创冠状动脉造影术和冠状动脉再血管化的数量。心脏CT在美国急诊室日益普及，扩大了其临床应用的机会，但也增加了定义其在评估急性胸痛患者中的适当使用的必要性。为了满足这一需求，我们建议在1000名中低可能性急性冠脉综合征患者中进行一项严格且动力充足的随机诊断试验，以确定将心脏CT及其提供的有关冠状动脉疾病(CAD)和左心室(LV)功能的信息整合到急性胸痛患者的诊断工作中的效率。患者将随机接受标准ED分诊或标准ED分诊辅以心脏CT检查。受试者可以入院，也可以出院。录取的受试者将接受进一步的评估和测试。然后，我们将确定CT是否增加了ED的直接出院率，减少了住院时间，而不增加了有创冠状动脉造影的数量。为了严格评估心脏CT是否也具有成本效益，我们将比较每种策略的30天成本，然后进行决策和经济马尔可夫模型，以估计两种策略的质量调整后预期寿命和寿命医疗成本。总体而言，我们希望这项试验将提供一个明确的答案，即心脏CT是否可以有效地用于患者直接从急诊室出院，并澄清AHA/ACC IA级建议是否合理。公共卫生相关性：心脏CT技术将很快在美国的大多数急诊科使用。虽然一些专家已经在推广在急性胸痛患者中使用心脏CT，但只有经过充分设计和动力的多中心随机诊断试验才能提供证据表明使用心脏CT是否合理，因为它与标准护理一样安全，但更有效。最好的情况是，这项研究将为专业协会提供充分的信息，以证明在急诊胸痛患者的急诊评估中使用心脏CT的建议(即发布IA级建议)是合理的。

DESCRIPTION (provided by applicant): This application represents the Clinical Coordinating Center of the overall proposal. Patients with acute chest pain and normal or non-diagnostic electrocardiograms (ECGs) represent a cohort whose management is notably inefficient and diagnostically challenging. Typical diagnostic testing that would allow physicians to rule out the occurrence of myocardial ischemia (e.g. nuclear imaging, echocardiography, and exercise treadmill ECG) is often not available for the initial emergency department (ED) evaluation, most of these patients are hospitalized for 24 to 36 hours to exclude the presence of acute coronary syndrome (ACS). Of the six million acute chest pain patients admitted each year in the U.S. under these conditions, <10% ultimately receive a diagnosis of ACS. Moreover, inpatient care for negative evaluations imparts an economic burden in excess of $8 billion annually. Recent advances in cardiac computed tomography (CT) technology allow for accurate detection of coronary atherosclerotic plaque and stenosis, and also allow physicians to assess global and regional LV function. Blinded observational studies demonstrate that absence of coronary atherosclerotic plaque as detected by cardiac CT is a powerful predictor of the absence of ACS (negative predictive value [NPV] of 100%). Thus, the implementation of cardiac CT in the early ED triage process may enable immediate and safe discharge of a significant fraction of acute chest pain patients without further testing. However, it is equally important to determine the effect of cardiac CT on the management of admitted patients, in particular the length of hospital stay, the number of invasive coronary angiograms, and coronary revascularizations. The growing availability of cardiac CT in EDs across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we propose to perform a rigorous and adequately powered randomized diagnostic trial in 1000 subjects with low to intermediate likelihood of ACS to determine the efficiency of integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, into the diagnostic workup of patients with acute chest pain. Patients will be randomized to receive the standard ED triage or the standard ED triage supplemented with a cardiac CT. Subjects will either be admitted or discharged. Admitted subjects will undergo further evaluation and testing. We will then determine whether CT increases the rate of direct ED discharges, decreases the length of hospital stay while not increasing the number of invasive coronary angiograms. To critically evaluate whether cardiac CT is also cost-effective, we will compare the 30-day costs for each strategy and subsequently perform decision and economic Markov modeling to estimate quality adjusted life expectancy and life-time medical costs of the two strategies. Overall, we hope this trial will provide a definitive answer as to whether cardiac CT can be efficiently used to discharge patients directly from the ED and clarify whether an AHA/ACC class IA recommendation is justified. Public Health Relevance: Cardiac CT technology will soon become available to most emergency departments in the United States. While some experts already promote the use of cardiac CT in patients with acute chest pain, only an adequately designed and powered multi-center randomized diagnostic trial will provide evidence whether the use of cardiac CT is justified because it is equally safe but more effective than standard care. Optimally this study will provide professional societies with adequate information to justify recommendations on the use of cardiac CT (i.e. by issuing a class IA recommendation) in the ED evaluation of patients with acute chest pain.