Creation and Implementation of a Prospective and Multicentric Database of Patients with Acute Myocardial Infarction: RIAM

Vaz, Jacqueline; Abelin, Anibal Pereira; Schmidt, Marcia Moura; Oliveira, Pedro Piccaro de; Gottschall, Carlos A. M.; Rodrigues, Clarissa Garcia; Quadros, Alexandre Schaan de

doi:10.36660/abc.20190036

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Original Article • Arq. Bras. Cardiol. 114 (3) • May-Jun 2020 • https://doi.org/10.36660/abc.20190036 copy

Creation and Implementation of a Prospective and Multicentric Database of Patients with Acute Myocardial Infarction: RIAM

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Background

Multicenter registries representing the real world can be a significant source of information, but few studies exist describing the methodology to implement these tools.

Objective

To describe the process of implementing a database of ST-segment elevation acute myocardial infarction (STEMI) at a reference hospital, and the application of this process to other centers by means of an online platform.

Methods

In 2009, our institution implemented an Registry of Acute Myocardial Infarction (RIAM), with the prospective and consecutive inclusion of every patient admitted to the institution who received a diagnosis of STEMI. From March 2014 to April 2016, the registries were uploaded to a web-based system using the REDCap software and the registry was expanded to other centers. Upon subscription, the REDCap platform is a noncommercial software made available by Vanderbilt University to institutions interested in research.

Results

The following steps were taken to improve and expand the registry: 1. Standardization of variables; 2. Implementation of institutional REDCap (Research Electronic Data Capture); 3. Development of data collection forms (Case Report Form - CRF); 4. Expansion of registry to other reference centers using the REDCap software; 5. Training of teams and participating centers following an SOP (Standard Operating Procedure).

Conclusion

The description of the methodology used to implement and expand the RIAM may help other centers and researchers to conduct similar studies, share information between institutions, develop new health technologies, and assist public policies regarding cardiovascular diseases. (Arq Bras Cardiol. 2020; 114(3):446-455)

Myocardial Ischemia/physiopathology; Cardiovascular Diseases/mortality; Myocardial Infarction/physiopathology; Multicenter Study; Database; Public Health Policy

A. Demographic Data	Variable in English	Legend	Selection
Last name	Last_name	Indicates the patient's last name
First name	first_name	Indicates the patient's first name
Patient’s identification number	Patient_ID	Indicates the number entered automatically by the software that uniquely identifies this patient
Date of birth	Birth_date	Indicates the date of birth of the patient
Sex	Sex	Indicates the patient's sex at birth	Male; Female
B. Admission Data	Variable in English	Legend	Selection
Patient’s ZIP code	patient_zip_code	Indicates the zip code of the patient’s primary home
Date of admission	admission_date	Indicates the date the patient was admitted to the institution for the treatment of the current episode
Private health plan	insurance_payor_private	Indicates whether the patient's insurance payor includes a private health plan	No; Yes
C. Clinical Data	Variable in English	Legend	Selection
Date of symptom onset	symptom_onset_date	Indicates the date the patient first reported ischemic symptoms for 10 minutes or more.
Date of first ECG	first_ECG_date	Indicates date of first 12-lead electrocardiogram
Heart failure	heart_failure	Indicates the existence of heart failure on first medical contact	No, Yes
Cardiogenic shock	cardiogenic_shock	Indicates whether the patient was in cardiogenic shock on first medical contact	No, Yes
Heart rate	heart_rate	Indicates the first heart rate record (in beats per minute)
Systolic blood pressure	systolic_blood_pressure	Indicates first record of systolic blood pressure in mmHg
Cardiac arrest	cardiac_arrest	Indicates whether the patient was in cardiac arrest on first medical contact	No, Yes

Demographics	Database
Patient ID	RIAM of ACCESS
Birth Date	RIAM of ACCESS
Sex	RIAM of ACCESS
Race	RIAM of ACCESS
Admission	Database
Prior MI	RIAM of ACCESS
Prior angina	RIAM of ACCESS
Systemic Systolic Blood Pressure	RIAM of ACCESS
Systemic Diastolic Blood Pressure	RIAM of ACCESS
Risk factors	Database
Diabetes	RIAM of ACCESS
Dyslipidemia	RIAM of ACCESS
Prior CVA	RIAM of ACCESS
Prior CABG	RIAM of ACCESS
Hypertension	RIAM of ACCESS
Tobacco use	RIAM of ACCESS

Demographics	Database
Patient ID	ACTION Registry®
Birth Date	ACTION Registry®
Sex	ACTION Registry®
Race	ACTION Registry®
Admission	Data Base
Prior MI	ACTION Registry®
Prior angina	ACTION Registry®
Systemic Systolic Blood Pressure	ACTION Registry®
Systemic Diastolic Blood Pressure	ACTION Registry®
Risk factors	Data Base
Diabetes	ACTION Registry®
Dyslipidemia	ACTION Registry®
Prior CVA	ACTION Registry®
Prior CABG	ACTION Registry®
Hypertension	ACTION Registry®
Tobacco use	ACTION Registry®

Name of Instrument	Fields	Session of Registries
Demographic data	6	Patient identification; date of birth; age; health insurance payor; education; race; sex.
Contacts	4	Main phone number; second phone number; family member’s phone number; patient’s e-mail address.
Clinical data 24h	18	Symptoms and initial care; Onset of ischemic discomfort; origin; ECG data; MI wall; Vital Signs and Physical Examination; Reperfusion Strategy.
Medication 24h	23	Medication given for 24h.
Clinical History	22	Height; Weight; BMI; DM; Tobacco user; HAS; Dyslipidemia; Angina; AMI; ACTP; CRM; Cardiac insufficiency; Family history; CVA; Chronic Kidney Failure; cancer; antidepressant; Peripheral arterial disease; FA and Flutter; Previous cardiac device.
Catheterization and Intervention	34	Cardiac Catheterization and ACTP Data; Angiography findings; Angioplasty data; Angiographic aspects;
Laboratory data - admission	20	Laboratory tests performed on admission; Positive myocardial injury markers within first the 24 hours.
Procedures and complications - hospitalization	26	Infarction Type; Procedures until discharge; Complications until discharge.
Data from hospital discharge form	9	Death before hospital discharge; Date of hospital discharge; Length of hospital stay; Medication prescribed at hospital discharge; MACE during hospitalization.
Outcome and follow-up	24	Records/Patient/Family information; Date of contact; death; Cause of death; Hospitalization since last contact; MI since last contact; Angina; CA since last contact; CVA since last contact: ICP since last contact; CRM since last contact; Intra-stent restenosis; MACE; Review contact information.

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E-mail: revista@cardiol.br

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[1] Mailing Address: Alexandre Schaan de Quadros • Instituto de Cardiologia - Av. Princesa Isabel, 395. Postal Code 90620-000, Porto Alegre, RS – Brazil E-mail: quadros.pesquisa@gmail.com