Study protocol of the PEruvian registry of STsegment elevation myocardial infarction II (PERSTEMI-II) study

Abstract

Background 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. Methods and analysis 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). Discussion 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.