BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-042936 on 25 May 2021. Downloaded from Protocol for the Acute Myocardial Infarction Study in Northeastern China (AMINoC): a real-world prospective cohort study ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-042936 Article Type: Protocol Date Submitted by the 20-Jul-2020 Author: Complete List of Authors: Li, Tianyi; Jilin University Second Hospital, cardiology Wu, Junduo; Jilin University Second Hospital, cardiology Liu, Jia; Jilin University Second Hospital, Cardiology Sun, Wei; the Second Hospital of Jilin University, cardiology Qi, Chao; Jilin University Second Hospital, Cardiology Liu, Bin; Jilin University Second Hospital, Department of Cardiology Wells, George ; University of Ottawa, School of Epidemiology and Public Health; University of Ottawa Heart Institute, Cardiovascular Research Methods Centre Wang, Junnan; Jilin University Second Hospital, Cardiology Myocardial infarction < CARDIOLOGY, EPIDEMIOLOGY, Protocols & Keywords: guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT http://bmjopen.bmj.com/ on October 1, 2021 by guest. 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Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 17 1 2 3 4 Protocol for the Acute Myocardial Infarction Study in Northeastern China 5 BMJ Open: first published as 10.1136/bmjopen-2020-042936 on 25 May 2021. Downloaded from 6 7 (AMINoC): a real-world prospective cohort study 8 9 Tianyi Li1, Junduo Wu1, Jia Liu1, Wei Sun1, Chao Qi1, Bin Liu1, George Wells2, 10 11 Junnan Wang*, on behalf of Acute Myocardial Infarction Study in Northeastern 12 13 China (AMINoC) 14 15 16 17 1 Department of Cardiology, The Second Hospital of Jilin University, Changchun, 18 For peer review only 19 Jilin, China 20 21 2 Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, 22 23 Ottawa, Canada 24 25 26 27 28 *Corresponding author 29 30 Email adress: [email protected] 31 32 33 34 Word count (excluding title page, abstract, references, figures and tables): 2942 35 36 37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44 45 on October 1, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 17 BMJ Open 1 2 3 4 Abstract 5 BMJ Open: first published as 10.1136/bmjopen-2020-042936 on 25 May 2021. Downloaded from 6 Introduction: Acute myocardial infarction (AMI) has become one of the major 7 8 causes of mortality and morbidity in China. However, little is known about the 9 10 characteristics, medical care, and outcomes of AMI patients in northeastern China. 11 The Acute Myocardial Infarction Study in Northeastern China (AMINoC) is aimed at 12 13 obtaining timely real-world knowledge in terms of characteristics, clinical care, and 14 15 outcomes of AMI patients and at providing care-quality improvement efforts in 16 17 northeastern China. 18 For peer review only 19 Methods and analysis: The AMINoC is a real-world, prospective, multicenter cohort 20 21 study. The study selected 20 hospitals using stratified cluster sampling from different 22 23 levels of hospitals among nine districts throughout Jilin Province. Hospitalized 24 25 patients with a primary diagnosis of AMI in each site are consecutively enrolled for 1 26 27 year. Demographic characteristics, clinical data, treatments, outcomes, and cost are 28 29 collected by local investigators. Patient follow-up after discharge is planned for up to 30 31 2 years. 32 33 Ethics and dissemination: The protocol has been approved by the ethics committee 34 35 at the Second Hospital of Jilin University. The findings of this study will be published 36 37 in peer-reviewed journals and medical conferences. http://bmjopen.bmj.com/ 38 39 Registration: The study is registered at Clinical Trials (NCT 04451967). 40 41 Keywords: acute myocardial infarction, prospective, observational, protocol, 42 43 44 45 Strengths and limitations of this study on October 1, 2021 by guest. Protected copyright. 46 47 This is a real-world, multicenter, prospective study of hospitalized AMI patients 48 49 throughout northeastern China. 50 A comprehensive understanding of the epidemiology, real-world clinical practice, 51 52 outcomes, and medical cost of hospitalized AMI patients in northeastern China 53 54 will be obtained from this study. 55 56 Possible heterogeneity of patients and practices may influence some aspects of 57 58 the data collection. 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 17 1 2 3 4 INTRODUCTION 5 BMJ Open: first published as 10.1136/bmjopen-2020-042936 on 25 May 2021. Downloaded from 6 Acute myocardial infarction (AMI) is among the leading causes of morbidity and 7 8 mortality worldwide, with more than 7 million cases annually,[1] thus causing a great 9 10 economic burden. Although AMI mortality has been reduced in western countries 11 during the past decades due to evidence-based therapies,[1-3] the incidence of AMI is 12 13 increasing sharply in China.[4] Several factors are responsible for this increase: first, 14 15 improving medical care decreased the mortality of infectious diseases, leading to a 16 17 shift of the main disease burden in China from infectious diseases to non-infectious 18 For peer review only 19 diseases, including AMI;[5] second, with the increase in lifespan and economic 20 21 development, the prevalence of non-infectious diseases such as hypertension, 22 23 diabetes, and hyperlipidemia, many of which are risk factors of AMI, steadily 24 25 increased during the past decades;[6] lastly, as the increasing urbanization and 26 27 lifestyle of Chinese residents tend to have less physical activity and more cigarette 28 29 and alcohol consumption,[7, 8] all of which are risk factors for cardiovascular disease. 30 31 Despite the increasing incidence of AMI in China, medical care has not improved 32 33 accordingly. Moreover, as economic development differs in urban and rural areas, 34 35 hospital levels vary, and the medical care received by AMI patients may also 36 37 differ.[9] Hospitals in China are classified as primary (community hospitals with only http://bmjopen.bmj.com/ 38 39 the most basic facilities and with very limited inpatient capacity), secondary (hospitals 40 41 with at least 100 inpatient beds providing acute medical care and preventative care 42 43 services to populations of at least 100,000), or tertiary (major tertiary referral centers 44 45 in provincial capitals and major cities) according to the Chinese National Health on October 1, 2021 by guest. Protected copyright. 46 47 Commission.[10] Urban areas have tertiary hospitals where AMI patients can directly 48 49 undergo primary percutaneous coronary intervention (PCI) treatment after 50 hospitalization, whereas in rural areas with a less developed economy, secondary 51 52 hospitals are the largest available hospitals, some of which are not capable of 53 54 performing primary PCI. Under this circumstance, AMI patients have to be 55 56 transferred to a tertiary hospital to obtain PCI treatment. Moreover, some patients may 57 58 be misdiagnosed or appropriate treatments in clinical practice may be delayed.[11, 12] 59 60 The increasing prevalence of AMI and inappropriate medical care indicate a severe For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 17 BMJ Open 1 2 3 4 AMI situation in China.