Trial Design The China Acute Myocardial Infarction (CAMI) Registry: A national long-term registry- research-education integrated platform for exploring acute myocardial infarction in China Haiyan Xu, MD, PhD, a Wei Li, PhD, a Jingang Yang, MD, a Stephen D. Wiviott, MD, b Marc S. Sabatine, MD, MPH, b Eric D. Peterson, MD, MPH, c Ying Xian, MD, PhD, c Matthew T. Roe, MD, MHS, c Wei Zhao, MBBS, a Yang Wang, MS, a Xinran Tang, BS, a Xuan Jia, BS, a Yuan Wu, MD, a Runlin Gao, MD, a and Yuejin Yang, MD, PhD a , on behalf of the CAMI Registry study group Beijing, China; MA, and NC, USA Background Acute myocardial infarction (AMI) has become a major cause of hospitalization and mortality in China. There has been limited data to date available to characterize AMI presentation, contemporary patterns of medical care, and outcomes in China. Aims The CAMI Registry is a national project with the objectives to timely obtain real-world knowledge about AMI patients and to provide the platform for clinical research, guide preventive measures and care quality improvement efforts in China. Methods and Progress The CAMI registry is a prospective, nationwide, multicenter observational study for AMI patients. The registry includes three levels of hospitals (representing typical Chinese governmental and administrative models) from all provinces and municipalities throughout Mainland China except Hong Kong and Macau. Sites were instructed to enroll consecutive patients with a primary diagnosis of AMI. Clinical data, treatments, outcomes and cost are collected by local investigators and captured electronically, with a standardized set of variables and standard definitions, and rigorous data quality control. Post-discharge patient follow-up to 2 years is planned. The CAMI Registry was launched in January 2013. A total of 108 hospitals have participated in the registry so far. As of September 2014, 26,103 patients with AMI were registered. Conclusions The CAMI registry represents a well-supported and the largest national long-term registry-research- education platform for surveillance, research, prevention and care improvement for AMI in China, the world's most populous nation. The broad representation of all provinces and different-level hospitals will allow for the exploration of AMI across diverse geographic regions and economic circumstances. (Am Heart J 2016;175:193-201.e3) The mortality of acute myocardial infarction (AMI) has reperfusion, effective antithrombotic therapy, and inten- been declining over the past 30 years in US and European sive evidence-based medication into routine clinical countries.1–3 The significant improvement in outcomes is practice.4,5 concurrent with the translation and integration of Whereas in China, the morbidity of ischemic heart evidence-based AMI care including early myocardial disease including AMI has sharply increased and become a major cause of emergency medical care, hospitalization and death over the past few decades.6,7 This increase in part represents economic and medical progress that has From the aFuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy led to declines in infectious diseases and a shift to chronic b of Medical Science and Peking Union Medical College, Beijing, China, TIMI Study Group, diseases in China.8,9 However, increasing urbanization, Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, and cDuke Clinical Research Institute, Duke University Medical Center, economic prosperity and western influences have also Durham, NC. increased consumption of animal fats, cigarette smoking, Clinical Trial Registration: http://www.clinicaltrials.gov Identifier: NCT01874691. and obesity, all leading to the marked increase in Submitted March 17, 2015; accepted April 9, 2015. cardiovascular diseases, especially in the younger and Reprint requests: Yuejin Yang, M.D., PhD, Department of Cardiology, Fuwai Hospital, 167 10,11 Beilishi Road, Beijing 100037, People’s Republic of China. rural population. The broad geography, unbalanced E-mail: [email protected] economy, different population, and varied life-styles in 0002-8703 China may bring about variation in prevalence and © 2015 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). clinical characteristics of AMI, but epidemiologic nation- http://dx.doi.org/10.1016/j.ahj.2015.04.014 wide data across the whole country is lacking. American Heart Journal 194 Xu et al May 2016 Moreover, there are several challenges with AMI care research and education platform (Figure 1). The database and outcomes in China. The medical care patterns of AMI will be openly shared to all the participating investigators have changed over the past decades. Health care systems for analyses and research. The project is currently funded are in the process of the reform in China, but still not as one of the National Twelfth Five-year Science and optimizedforthedramaticincreaseinAMIinci- Technology Support Projects by Ministry of Science and dence.12,13 Patients in different areas and population Technology of China (Grant No. 2011BAI11B02). It is may get differential access to hospitals and medical care organized and conducted by Fuwai Hospital, National which may lead to disparate outcomes.14,15 In routine Center for Cardiovascular Diseases of China (NCCD). clinical practice, we found many patients delayed The organizational structure of the CAMI registry is presentation to hospital and some patients were mis- displayed in Figure 2. The principal investigator (PI) is diagnosed.16,17 Still some patients being correctly diag- responsible for all aspects of the project, including the nosed didn’t receive effective, timely and appropriate management and integrity of the design, conduct, and treatments.18 But limited comprehensive data across report of the research project. The Scientific Committee China is available to understand the roles of these factors. consists of experienced American cardiologists and clinical Furthermore, it is unclear whether the strategies accord- trialists and Chinese cardiology leaders. The members of ing to evidence-based medicine and guidelines from Scientific Committee help to assure the scientific and western countries are completely applicable and optimal rational design of the registry, and supervise data for Chinese patients, due to differences between China collection, registry operation, quality control, and data and western countries. analysis. The Data Monitoring Committee is in charge of To date, China, the most populous country in the world, data quality evaluation and supervision. The members of with broad geography, varied life-styles and wide differ- Executive and Steering Committee manage the design and ences in socioeconomic status, and disparate medical care, execution of the registry. The Clinical Support Team has not had a representative national long-term registry consists of eight clinical cardiologists who are trained to be program for the patients with AMI. Therefore, we designed responsible for medical aspects in the registry, including and launched China AMI (CAMI) registry, a nationwide supporting the investigators, answering medical hotline, registry of the hospitalized patients with AMI as an and assist in the supervising of the registry process and integrated research and education platform in China. on-site audits. Project managers are in charge of coordinat- ing and managing the operational process. The Data Management and Statistics Teams are managed by Medical Methods Research and Biostatistics Center, NCCD. The Analysis and Objectives of the CAMI Registry Publication Committee is responsible for reviewing and The specific aims of the CAMI Registry are to (1) serve approving research proposal, and overseeing the genera- as a national long-term hospital-based registry and tion of abstracts and manuscripts from the database. Each surveillance program for AMI to timely obtain real-world hospital has a local study group, including local PI, research information about clinical characteristics, medical care coordinator, investigators, research assistants, and local and outcomes of Chinese patients with AMI across quality control person. The members of committees and different provinces, prefectures and counties; (2) analyze teams are listed in online Appendix A. risk factors and clinical presentations among different patients across different regions, and trends over time, to Ethical review and patient privacy develop scientific preventive strategies for AMI, especial- This project was approved by the institutional review ly among individuals at high risk; (3) aid in the board central committee at Fuwai Hospital, NCCD of development of effective strategies and update of China. The CAMI registry study group maintains the guidelines applicable to Chinese patients and, thus, institutional review board–approved protocol that de- improve medical quality and outcomes for AMI through scribes methods used to protect the privacy of patients implementation into clinical practice; (4) establish a and maintain confidentiality of data collected. Written risk-adjusted evaluation system of cost-effectiveness and informed consent is to be obtained from eligible patient clinical pathways suitable for Chinese AMI patients in before registration. However, to avoid a registration bias different-level hospitals and across different regions; (5) which informed consent may bring and to make sure