Instituto Nacional Cardiovascular, EsSalud, Lima, Peru.
Vicerrectorado de Investigación, Centro de Excelencia en Investigaciones Económicas y Sociales en Salud, Universidad San Ignacio de Loyola, Lima, Peru.
PLoS One. 2021 Sep 17;16(9):e0257618. doi: 10.1371/journal.pone.0257618. eCollection 2021.
Myocardial infarction (MI) is the most prevalent cardiovascular disease globally and is considered a public health problem. In Peru, MI is the second leading cause of death at the national level, with a mortality rate that exceeds 10% in the hospital setting. The study aims to determine the clinical and epidemiological characteristics of ST-segment elevation myocardial infarction (STEMI) in tertiary care facilities belonging to the Peruvian public health system.
This will be a prospective, observational, multicenter study, with baseline and two follow-up assessments: at admission to the health service, and 30 days and 12 months after admission. This multicenter study will be conducted in 27 hospitals located in the main cities of Peru. The patients included in the study will be over 18 years of age, of either sex, and will have been admitted to the health facility with a diagnosis of acute coronary syndrome with ST-segment elevation. The Kaplan-Meier method will be used to estimate the cumulative in-hospital mortality of patients at 30 days and 12 months of follow-up, and the log-rank test will be used to evaluate the differences between the survival curves between reperfused and non-reperfused patients. Subsequently, to evaluate the risk factors for successful reperfusion and cardiovascular adverse events, generalized linear models of the binomial family with log link function will be used to estimate the bivariate and multivariate relative risk (RR) with their respective 95% confidence intervals. This project was approved by the Ethics and Research Committee of the National Cardiovascular Institute (Instituto Nacional Cardiovascular "Carlos Alberto Peschiera Carrillo"-INCOR [in Spanish]; Approval report 21/2019-CEI).
Among the strengths, the observational design will allow the inclusion of a large sample of patients, which will significantly contribute to the knowledge base on STEMI in Peru. It should be noted that this study is the first to examine the clinical-epidemiological characteristics of STEMI in high-resolution hospital centers in Peru with follow-up one year after the event, providing knowledge of these observable characteristics in daily clinical routine. Likewise, the multicenter nature of the study will increase the external validity of the findings. In terms of limitations, the observational design of the study can only describe associations and not causality. Furthermore, since data from medical records will be used, there could be imprecision in the data.
心肌梗死（MI）是全球最常见的心血管疾病，被认为是一个公共卫生问题。在秘鲁，MI 是全国范围内的第二大死因，医院死亡率超过 10%。本研究旨在确定秘鲁公立医疗系统内的三级保健机构中 ST 段抬高型心肌梗死（STEMI）的临床和流行病学特征。
这将是一项前瞻性、观察性、多中心研究，包括基线和两次随访评估：在卫生服务机构入院时，以及入院后 30 天和 12 个月。这项多中心研究将在秘鲁主要城市的 27 家医院进行。研究纳入的患者年龄大于 18 岁，无论性别，均因诊断为急性冠状动脉综合征伴 ST 段抬高而入住医疗机构。将使用 Kaplan-Meier 法估计 30 天和 12 个月随访时患者的累积院内死亡率，并使用对数秩检验评估再灌注与未再灌注患者间生存曲线的差异。随后，为评估成功再灌注和心血管不良事件的风险因素，将使用二项式家族的广义线性模型和对数链接函数来估计双侧和多变量相对风险（RR）及其各自的 95%置信区间。该项目获得了国家心血管研究所伦理与研究委员会的批准（Instituto Nacional Cardiovascular "Carlos Alberto Peschiera Carrillo"-INCOR [西班牙语]；批准报告 21/2019-CEI）。
本研究的优势之一是观察性设计可纳入大量患者，这将显著丰富秘鲁 STEMI 的知识库。值得注意的是，这是第一项在秘鲁高分辨率医院中心研究 STEMI 的临床流行病学特征，并在事件发生后一年进行随访，提供了日常临床实践中这些可观察特征的知识。同样，该研究的多中心性质将提高研究结果的外部有效性。研究的局限性在于，观察性设计只能描述关联，而不能确定因果关系。此外，由于将使用病历数据，数据可能存在不精确性。
