A Multi-Center Prospective Registration and Cohort Study on Prognosis and Predictors of Acute Myocardial Infarction in Japan.

治疗技术的进步为改善急性心肌梗死(AMI)的预后做出了贡献，但在包括日本在内的亚洲地区，有关医疗实践模式、影响AMI预后的其他因素及其对实际健康结局的影响的临床证据有限。本研究旨在探讨影响急性心肌梗死患者预后的因素，特别参考生活质量，并对治疗结果进行经济学评价。这是一项多中心前瞻性队列研究。研究对象为20至79岁的急性心肌梗死(首次或复发)患者，他们与以下大学医院之一合作访问：岩手医科大学、北里大学、日本医科大学、东京医科大学、大阪市立大学。大学医学信息网(UMIN)提供的在线登记系统将用于登记那些给予书面同意并愿意参与这项研究的患者。将设立官方批准的独立个人信息中心，以确保在后续调查期间始终保护隐私。主要观察指标为出院6个月后用SF-36和EQ5D进行的生活质量评估。331例患者(男289例，女42例)在出院一年内发生严重血管事件(如再发冠状动脉事件和脑血管意外)以及因严重血管事件死亡而死亡的记录将被归档。随访期内再入院7例，死亡6例。总随访率在80%以上。该数据库是为队列研究开发的，可用于未来分析包括主观生活质量在内的临床结果的预测因素。将对数据集进行多变量分析，如COX回归分析。

The advances in the treatment techniques have contributed to improving prognosis of acute myocardial infarction (AMI), however, clinical evidence are limited in Asia including Japan about medical practice patterns as well as other factors influencing AMI prognosis and their effect on the actual health outcome. This study aims to examine the factors influencing prognosis with special reference to QOL after AMI, and to carry out an economic evaluation of the treatment outcome.This is a multi-center prospective cohort study. Subjects are 20-to-79 year-old patients with (first or recurrent) AMI who visit one of the university hospitals in collaboration as follows : Iwate Medical University, Kitasato University, Nippon Medical University, Tokyo Medical University, Osaka City University. An online registry system provided by the University Medical Information Network (UMIN) will be used to register those patients giving written consent and willing to participate in this study. An officially approved independent personal information center will be set up in order to guarantee privacy protection all along the follow-up survey. The main outcome measures are QOL evaluated by SF-36 and EQ5D six months after discharge from hospital. Records of the incidence of serious vascular events (such as recurrent coronary events and cerebrovascular accidents) as well as of deaths that result from such events occurring within a year of discharge will be filed.Finally, 331 cases (men : 289, women : 42) participated in this study for a period of two years and subsequently were followed up for one year after discharge from hospital. Within the follow up period, 7 cases readmitted the hospital and 6 cases died. Overall follow-up rate was over 80%. The database, which was developed for the cohort study, is available for the future analysis of predictors of clinical outcomes including subjective QOL. Multivariate analyses such as Cox regression analysis will be applied for the data set.