Time to Treatment and In-Hospital Major Adverse Cardiac Events Among Patients With ST-Segment Elevation Myocardial Infarction Who Underwent Primary Percutaneous Coronary Intervention (PCI) According to the 24/7 Primary PCI Service Registry in Iran: Protocol for a Cross-Sectional Study

Abstract

BackgroundPatients with ST-segment elevation myocardial infarction (STEMI) experience major adverse cardiac events (MACEs) following primary percutaneous coronary intervention (PCI). Although the relationship between time to treatment (eg, door-to-balloon time, symptom onset-to-balloon time, and symptom onset-to-door time) and 1-month all-cause mortality was assessed previously, its relationship with in-hospital MACEs and the effect of some clinical characteristics on this relationship were not considered. Furthermore, previous studies that were conducted in developed countries with a different quality of care cannot be applied in Iran, as Iran is a developing country and the studies were not performed according to the 24/7 primary PCI service registry.ObjectiveThe objective of this study protocol is to determine the relationship between time to treatment and in-hospital MACEs.MethodsThis cross-sectional study will take place at the Tehran Heart Center (THC), which is affiliated with Tehran University of Medical Sciences (TUMS) in Tehran, Iran. Data related to patients with STEMI, who underwent primary PCI between March 2015 and March 2019, that have been prospectively recorded in the THC’s 24/7 primary PCI service registry will be analyzed. The study outcome is the occurrence of in-hospital MACEs. Data analysis will be conducted using SPSS for Windows, version 16.0 (SPSS Inc). We will perform chi-square tests, independent-samples t tests, or the Mann-Whitney U test, as well as univariate and multivariate binary logistic regression with a significance level of less than .05 and 95% CI for odds ratios.ResultsFrom March 2015 to September 2017, 1586 patients were included in the THC service registry, consecutively. We will conduct a retrospective analysis of this registry on patient entries between March 2015 and March 2019 and data will be analyzed and published by the end of 2019.ConclusionsTo our knowledge, this is the first observational study based on the 24/7 primary PCI service registry in Iran. The findings of this study may reveal current problems regarding time to treatment in STEMI management in the THC. Results from this study may help determine appropriate preventive strategies that need to be applied in order to reduce time-to-treatment delays and improve patients’ outcomes following primary PCI in the setting of STEMI at the THC and similar clinical centers.International Registered Report Identifier (IRRID)DERR1-10.2196/13161

Time to Treatment and In-Hospital Major Adverse Cardiac Events Among Patients With ST-Segment Elevation Myocardial Infarction Who Underwent Primary Percutaneous Coronary Intervention (PCI) According to the 24/7 Primary PCI Service Registry in Iran: Cross-Sectional Study

“…We conducted an observational study according to the 24/7 primary PCI service registry of THC in Iran. Details of the study design and setting have been published previously [ 26 ]. The study protocol was approved by the institutional review board and research ethics committee of Tehran University of Medical Sciences.…”

“…Inclusion criteria for this study were age older than 18 years, confirmed diagnosis of STEMI, and primary PCI through a standard technique without bolus administration of fibrinolytic agents in the catheterization laboratory of THC. Those with incomplete data regarding one of the time to treatment variables (eg, symptom-to-door time, door-to-balloon time, and symptom-to-balloon time) and the study outcome (ie, in-hospital MACCEs) were excluded from the analysis [ 26 ].…”

“…We used the registered data in the 24/7 primary PCI service registry as the main source of data. Details of the registry have been previously published [ 26 ]. Collected data from the time of admission to the emergency department (ED) to transfer to the catheterization laboratory through the STEMI management registry form were entered in the 24/7 primary PCI service registry by research staff weekly [ 26 ].…”

“…Details of the registry have been previously published [ 26 ]. Collected data from the time of admission to the emergency department (ED) to transfer to the catheterization laboratory through the STEMI management registry form were entered in the 24/7 primary PCI service registry by research staff weekly [ 26 ]. A flow chart of patient admission to the ED and transfer to the catheterization laboratory of THC has been published previously [ 28 ].…”

“…We explained study variables in the study protocol completely [ 26 ]. Demographic and clinical variables were recorded.…”