ABC | Volume 114, Nº3, March 2020

Original Article Vaz et al. RIAM – registry of acute myocardial infarction Arq Bras Cardiol. 2020; 114(3):446-455 to expand the registry to reference hospitals treating STEMI across the national territory. This took place fromMarch 2014 to April 2016 and included the standardization of variables; the implementation of dedicated software (REDCap); the development of data collection forms; and the inclusion of new centers with staff training. RIAM and the expansion to other centers RIAM is a prospective and consecutive clinical registry of STEMI patients treated at IC/FUC, in Porto Alegre/RS, Brazil. The registry was started in 2009 and currently has more than 3,500 patients. This initiative contributed to new studies with ideas for scientific and technological research in the institution. 12 IC/FUC will coordinate the expansion to seven other national centers, initially. Eligibility and workflow The inclusion criteria were patients aged at least 18 years old and STEMI with less than 12 hours of symptoms. Patients with more than 12 hours of symptoms and reporting chest pain at admission are also included. The registry was approved by the Ethics Committee of IC/FUC number 5025/14, with registration in Plataforma Brasil (CAAE: 38352714.0.0000.5333), and each participating center will also submit it for approval in their local institutional ethics committees. All patients are required to sign an informed consent form and their data will be collected in accordance with the principles of the current revision of the Declaration of Helsinki and the latest version of the Good Clinical Practice Guidelines (ICH-GCP), as well as Resolution 466/12 of the Brazilian National Health Council. 13-15 The study was expanded according to Brazilian legal and regulatory requirements. Results Registry design The following steps were taken to migrate the system to the online database and expand the registry, as shown in Figure 1: Step 1. Standardization of variables; Step 2. Implementation of institutional REDCap software ; Step 3. Development of data collection forms (Case Report Form - CRF); Step 4. Expansion of registry to other reference centers using the REDCap software; Step 5. Creation of SOPs (Standard Operating Procedures) for training teams and participating centers. Standardization of variables The nomenclature assigned to the variables already used in the Microsoft Access™ database were compared with internationally standardized variables to ensure the information in the registry is compatible with other national and international databases. Variables were standardized based on the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) clinical data standards for acute coronary syndromes and coronary artery diseases, published in 2013. They were also based on data element forms from the National Cardiovascular Data Registry (NCDR), the ACTION Registry®-GWTG™ (NCDR® ACTION Registry®-GWTG™ v2.4 Coder's Data Dictionary, replaced by the NCDR® Chest Pain - MI Registry™ v3.0 Coder's Data Dictionary as of June 2018), an ACCF-coordinated quality care program for patients with MI. 16,17 For national data regarding ethnicity the classification recommended by the Brazilian Institute of Geography and Statistics (IBGE) 18 was used. In addition, a review of the standardized data used by the Brazilian Society of Cardiology was carried out to facilitate international and national interoperability. 9 Table 1 shows some of the variables selected for the registry according to the NCDR ACTION Registry®. 17 Among the selected variables, the RIAM and ACTION Registry® – GWTG™ databases were found to have a similar profile across variables, suggesting that the RIAM (Table 2) already had a pattern comparable to the main MI registries in the world today (Table 3). Subsequently another spreadsheet was generated containing the sessions of registry with the number of fields to be included in REDCap CRF (Table 4). A codebook in English was included for each variable to enable smoother integration with other national and international databases, and an interface in portuguese was added for data collection in Brazil. Deployment of REDCap software REDCap was the software used by means of an online platform. It is internationally acknowledged for its security and applicability for clinical data capture and storage. The system is based on the international model by the Duke Clinical Research Institute, complying with international security requirements as well as with the Brazilian National Health Surveillance Agency (ANVISA). 19,20 Some of the features of REDCap are: (1) an intuitive interface for validated data entry, with automated data type and range checks; (2) audit trails for tracking data manipulation and export procedures, (3) automated data export procedures for common statistical packages and (4) procedures for importing data from external sources. 21 Data collection is performed on any device with internet access such as a computer, tablet or smartphone, or even offline via the REDCap application, which synchronizes the data once there is internet access. 22 REDCap is a noncommercial secure web-based database management solution offered by the Center for Research Informatics (CRI). It is used for the collection and management of research data and was developed following guidelines from the Health Insurance Portability and Accountability Act (HIPAA). 23 After obtaining a license from Vanderbilt University, the software was hosted on a local server protected by the IC/FUC system firewall. Access requires an individual username and password requested and approved by the local software manager at the institution. REDCap allowed the creation of a CRF, which contained the standardized variables of the study. 447