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Rationale and design of the long‐Term rIsk clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post–myocardial infarction patients (TIGRIS) study

机译:心肌梗死后研究(TIGRIS)的长期风险临床管理和医疗保健的原理和设计稳定冠状动脉疾病的资源利用

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摘要

The long‐term progression of coronary artery disease as defined by the natural disease course years after a myocardial infarction (MI) is an important but poorly studied area of clinical research. The long‐Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post–myocardial infarction patients (TIGRIS) study was designed to address this knowledge gap by evaluating patient management and clinical outcomes following MI in different regions worldwide. TIGRIS ( Identifier: ) is a multicenter, observational, prospective, longitudinal study enrolling patients with history of MI 1 to 3 years previously and high risk of developing atherothrombotic events in a general‐practice setting. The primary objective of TIGRIS is to evaluate clinical events (time to first occurrence of any event from the composite cardiovascular endpoint of MI, unstable angina with urgent revascularization, stroke, or death from any cause), and healthcare resource utilization associated with hospitalization for these events (hospitalization duration and procedures) during follow‐up. Overall, 9225 patients were enrolled between June 2013 and November 2014 and are being followed in 369 different centers worldwide. This will allow for the description of regional differences in patient characteristics, risk profiles, medical treatment patterns, clinical outcomes, and healthcare resource utilization. Patients will be followed for up to 3 years. Here we report the rationale, design, patient distribution, and selected baseline characteristics of the TIGRIS study. TIGRIS will describe real‐world management, quality of life (self‐reported health), and healthcare resource utilization for patients with stable coronary artery disease ≥1 year post‐MI.
机译:心肌梗塞(MI)后多年的自然病程定义了冠状动脉疾病的长期进展,这是重要的但临床研究较少的领域。心肌梗死后患者(TIGRIS)研究中稳定冠状动脉疾病的长期风险,临床管理和医疗资源利用旨在通过评估全球不同地区MI后的患者管理和临床结局来弥补这一知识差距。 TIGRIS(Identifier:)是一项多中心,观察性,前瞻性,纵向研究,纳入了1至3年以前有MI史且在一般情况下发生动脉粥样硬化血栓形成事件的高风险患者。 TIGRIS的主要目标是评估临床事件(从MI的复合心血管终点到首次发生任何事件的时间,伴有紧急血运重建的中风性心绞痛,中风或任何原因导致的死亡),以及与住院相关的医疗资源利用随访期间发生的事件(住院时间和程序)。在2013年6月至2014年11月之间,总共招募了9225名患者,并在全球369个不同的中心进行随访。这将允许描述患者特征,风险特征,药物治疗模式,临床结果和医疗资源利用方面的区域差异。将对患者进行长达3年的随访。在这里,我们报告了TIGRIS研究的基本原理,设计,患者分布和选定的基线特征。 TIGRIS将描述MI后≥1年的稳定型冠状动脉疾病患者的现实管理,生活质量(自我报告的健康状况)和医疗资源利用情况。

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