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

使用计算机辅助断层扫描排除心肌梗塞-ROMICATII，DCC

• 批准号: 7580254
• 负责人: DAVID Alan SCHOENFELD
• 金额: $ 38.32万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-15 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7580254
• 关键词: Accident and Emergency department; Acute; Address; Angiography; Arterial Fatty Streak; Biometry; Blinded; Cardiac; Caring; Chest Pain; Clinical; Communication; Consult; Coronary; Coronary Arteriosclerosis; Data; Data Coordinating Center; Detection; Diagnosis; Diagnostic; Diagnostic Trial; Diagnostic tests; Echocardiography; Economic Burden; Economics; Electrocardiogram; Electronics; Evaluation; Exercise; General Hospitals; Head; Hour; Image; Inpatients; Lead; Left Ventricular Function; Length of Stay; Life; Life Expectancy; Massachusetts; Medical; Medicine; Monitor; Myocardial Infarction; Myocardial Ischemia; Nuclear; Observational Study; Outcome Study; Patient Discharge; Patients; Physicians; Predictive Value; Process; Radiology Specialty; Randomized; Recommendation; Reporting; Site; Societies; Stenosis; Technology; Testing; Time; Triage; United States; X-Ray Computed Tomography; acute coronary syndrome; clinical application; cohort; cost; cost effective; data management; design; evaluation/testing; markov model; professor; protocol development; public health relevance; standard care; statistical center; tomography

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.

描述（由申请人提供）： 该申请代表了总体建议的临床协调中心。患有急性胸痛，正常或非诊断心电图（ECG）的患者代表了一个队列，其治疗效率显着效率低下且具有挑战性。典型的诊断测试将使医生可以排除心肌缺血的发生（例如核成像，超声心动图和运动跑步机ECG）通常不可用于初始急诊科（ED）评估，其中大多数患者大多数患者已住院24至36小时以排除急性冠状动脉综合征（ACS）。在这些条件下，在美国每年在美国接受600万急性胸痛患者中，<10％的患者最终诊断出ACS。此外，对负面评估的住院护理每年带来的经济负担超过80亿美元。心脏计算机断层扫描（CT）技术的最新进展允许准确检测冠状动脉粥样硬化斑块和狭窄，还允许医生评估全球和区域LV功能。盲目观察性研究表明，心脏CT检测到的冠状动脉粥样硬化斑块的缺失是ACS缺乏的有力预测指标（负预测值[NPV]为100％）。因此，在早期的ED分类过程中实施心脏CT可以立即安全地排除大量急性胸痛患者，而无需进一步测试。但是，确定心脏CT对入院患者的治疗的影响，特别是医院住院时间，侵入性冠状动脉血管造影和冠状动脉血运重建同样重要。美国EDS中心脏CT的可用性日益增长，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适当使用的必要性。为了满足这一需求，我们建议在1000名受试者中进行严格且充分的动力随机诊断试验，以确定整合心脏CT的效率，以及其在冠状动脉疾病（CAD）（CAD）和左心室（LV）功能中提供的信息，以诊断为诊断患者的诊断症患者。将随机分配患者，以接收标准的ED分类或补充心脏CT的标准ED分类。受试者将被录取或出院。被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是否会增加直接ED放电的速度，减少住院时间的长度，同时不增加侵入性冠状动脉造影的数量。为了批判性评估心脏CT是否也具有成本效益，我们将比较每种策略的30天成本，并随后执行决策和经济马尔可夫建模，以估算两种策略的质量调整后的预期寿命和终身医疗费用。总体而言，我们希望该试验将为是否可以有效地使用心脏CT直接从ED中排除患者，并阐明AHA/ACC类IA建议是否合理。公共卫生相关性：美国大多数急诊科很快就会使用心脏CT技术。尽管一些专家已经促进了急性胸痛患者的心脏CT使用，但仅设计和动力的多中心随机诊断试验将提供证据，这证据表明使用心脏CT是否合理，因为它同样安全，但比标准护理更有效。最佳地，本研究将为专业社会提供足够的信息，以证明在急性胸痛患者的ED评估中，在ED评估中使用心脏CT（即通过发布IA类建议）的建议是合理的。