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一项随机试验的原理与设计:比较初始负荷超声心动图与冠状动脉CT血管造影在低至中度风险的胸痛急诊科患者中的应用

Rationale and design of a randomized trial comparing initial stress echocardiography versus coronary CT angiography in low-to-intermediate risk emergency department patients with chest pain.

作者信息

Levsky Jeffrey M, Haramati Linda B, Taub Cynthia C, Spevack Daniel M, Menegus Mark A, Travin Mark I, Vega Shayna, Lerer Rikah, Brown-Manhertz Durline, Hirschhorn Esther, Tobin Jonathan N, Garcia Mario J

机构信息

Department of Radiology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, New York.

出版信息

Echocardiography. 2014 Jul;31(6):744-50. doi: 10.1111/echo.12464. Epub 2013 Dec 23.

DOI:10.1111/echo.12464
PMID:24372760
Abstract

BACKGROUND

Comparative effectiveness research (CER) has become a major focus of cardiovascular disease investigation to optimize diagnosis and treatment paradigms and decrease healthcare expenditures. Acute chest pain is a highly prevalent reason for evaluation in the Emergency Department (ED) that results in hospital admission for many patients and excess expense. Improvement in noninvasive diagnostic algorithms can potentially reduce unnecessary admissions.

OBJECTIVE

To compare the performance of treadmill stress echocardiography (SE) and coronary computed tomography angiography (CTA) in ED chest pain patients with low-to-intermediate risk of significant coronary artery disease.

DESIGN

This is a single-center, randomized controlled trial (RCT) comparing SE and CTA head-to-head as the initial noninvasive imaging modality. The primary outcome measured is the incidence of hospitalization. The study is powered to detect a reduction in admissions from 28% to 15% with a sample size of 400. Secondary outcomes include length of stay in the ED/hospital and estimated cost of care. Safety outcomes include subsequent visits to the ED and hospitalizations, as well as major adverse cardiovascular events at 30 days and 1 year. Patients who do not meet study criteria or do not consent for randomization are offered entry into an observational registry.

CONCLUSIONS

This RCT will add to our understanding of the roles of different imaging modalities in triaging patients with suspected angina. It will increase the CER evidence base comparing SE and CTA and provide insight into potential benefits and limitations of appropriate use of treadmill SE in the ED.

摘要

背景

比较效果研究(CER)已成为心血管疾病研究的主要重点,旨在优化诊断和治疗模式并降低医疗费用。急性胸痛是急诊科(ED)进行评估的一个非常普遍的原因,导致许多患者住院并产生额外费用。无创诊断算法的改进可能会减少不必要的住院。

目的

比较平板运动负荷超声心动图(SE)和冠状动脉计算机断层扫描血管造影(CTA)在患有中低风险显著冠状动脉疾病的急诊胸痛患者中的表现。

设计

这是一项单中心随机对照试验(RCT),将SE和CTA作为初始无创成像方式进行直接比较。测量的主要结局是住院发生率。该研究的样本量为400,旨在检测住院率从28%降至15%的情况。次要结局包括在急诊科/医院的住院时间和估计的护理费用。安全性结局包括随后到急诊科就诊和住院情况,以及30天和1年时的主要不良心血管事件。不符合研究标准或不同意随机分组的患者可进入观察性登记。

结论

这项RCT将增进我们对不同成像方式在对疑似心绞痛患者进行分诊中的作用的理解。它将增加比较SE和CTA的CER证据基础,并深入了解在急诊科适当使用平板运动负荷超声心动图的潜在益处和局限性。

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