Rationale and design of reGional network for Acute Myocardial Infarction (GAMI): protocol for a Prospective Cluster-randomized Intervention study of STEMI management

Abstract

BackgroundTimely revascularization is essential for ST-segment elevation myocardial infarction (STEMI) patients to reduced mortality rate. However, it's seldom achieved due to patient and medical system-level barriers in China, especially in the rural area. It's needed to establish a regionally coordinated network to promote the early revascularization rate for STEMI patients.MethodsRegional network for Acute Myocardial Infarction (GAMI) is a multi-center, prospective, intervention study with regional intervention. It was carried out in 8 centers by 1:1 cluster randomization in south China with diverse economic and medical levels since 2016. The regional intervention were carried out in the intervention centers, which consisted of intensive public education and regional network construction for STEMI treatment, including community and online propaganda to raised patients' awareness of the treatment for STEMI and establishment of regional clinic-EMS-PCI transfer network for timely primary revascularization. Consecutive acute STEMI patients were enrolled for assessment of regional intervention according to the key performance indicators. The primary study endpoint was reperfusion rate, and secondary endpoints included change of pre-hospital delay, changes of in-hospital delay time and in-hospital outcomes. All patients were followed up for more than 1 year.DiscussionThe GAMI study is a prospective cluster-randomized intervention study, which would provide helpful evaluation of the effectiveness of enhanced public education and regional network construction on regional STEMI treatmentTrial registration: Clinical Trials, NCT03928119. Registered , 25 April, 2019， https://clinicaltrials.gov/ct2/show/NCT03928119?id=NCT03928119&draw=2&rank=1