LATIN SHOCK: Registro Latinoamericano de Shock Cardiogénico en el Contexto de Los Sindromes Coronarios Agudos
Conditions: Cardiogenic Shock, Acute Coronary Syndrome
Sponsor: Sociedad Argentina de Cardiología

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Latin American Registry of 
Cardiogenic Shock in the 
context of Acute Coronary 
Syndromes 
(LATIN-Shock) 
  
  
  
  
  
  
  
 
 

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Investigation area 
Argentine Society of Cardiology 
 
 
  
  
  
  
  
Index 
Introduction ...........................................................3 
Objetives ..............................................................3 
Methods...............................................................3 
Study design 
Inclusion criteria 
Exclusion criteria 
Information gathering 
Statistic analysis 
Ethical considerations 
Study organization .................................................7 
Publications .......................................................7 
Bibliography .......................................................8 
 
 
 
 
 
 
 
 
 

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Introduction: 
 
 Cardiogenic shock is a rare disease, but it constitutes the main cause of 
mortality in patients hospitalized for acute myocardial infarction. Its incidence 
ranges between 7 and 10% of infarction cases 1 and it is associated with a 
mortality of 40-50% despite revascularization and the use of intra-Aortic Balloon 
Contrapulsation 2-3-4. 
 Most of the bibliography on this topic is North American, it is already many years 
old 5-6 and the one that is currently published mainly shows the results of different 
ventricular supports that are not commonly used in our environment 7 . So far 
there is no record that reports the reality of Latin America. Only in Argentina, has 
carried out a national registry of cardiogenic shock in the context of acute 
coronary syndromes but have already spent more than 5 years since its 
publication8. In recent years have even changed management guidelines this 
pathology 9-10 and works have been published that could have changed previous 
behaviors 11. 
 This is a project of the Argentine Society of Cardiology to collect epidemiological 
data and current management of cardiogenic shock in Latin America. 
  
  
Objetives: 
  
1- Determine the clinical characteristics of patients who are admitted to the 
coronary unit with acute coronary symptoms and present Cardiogenic Shock, 
either from admission or during their in-hospital evolution. 
2-  Analyze the treatment of patients with cardiogenic shock. 
3- Observe the clinical in-hospital evolution. 
4- Evaluates predictors of in-hospital mortality. 
5- Compare the clinic, management and evolution characteristics in the different 
participating Latin American countries. 
  
  
Methods: 
  
Study design: 
 It is an international, multicenter, observational, prospective and consecutive 
registry of patients with cardiogenic shock in the context of acute coronary 
syndromes, which will have a duration of 12 months starting on October 1, 2021. 
Coronary units from different Latin American countries will be invited to 
participate in the registry through the different cardiology societies. Each country 
and each participating center will be assigned a number and patients will be 
included in the registry in sequential order by center (1-2-3-etc) to maintain the 
confidentiality of the data. Since patient data will be extracted from medical 
records, records will be anonymous and there will be no follow-up, informed 

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consent will not be required. The names of the participating centers in the 
different countries will appear in a list at the end of the publications, under the 
collective name of “LATIN Shock group”. 
  
  
Definition of cardiogenic shock (classic): Presence of systolic blood pressure ≤90 
mm Hg for 30 minutes or requirement of vasopressors, inotropics and / or 
ventricular supports to maintain a blood pressure ≥90 mmHg, associated with 
signs of hypoperfusion and pulmonary congestion, in the absence of hypovolemia 
or arrhythmias that justify the clinical picture. 
A new definition of cardiogenic shock has recently been proposed, which includes 
5 categories12: 
A- At risk: Patient who does not present signs or symptoms of cardiogenic 
shock but is at risk of presenting it. Includes acute myocardial infarction, 
previous infarction, decompensated acute or chronic heart failure. 
B- Pre-shock: It is defined when there is tachycardia or hypotension without 
hypoperfusion. These patients must be closely monitored and carefully 
treated to avoid the development of classic cardiogenic shock. 
C- Classic: Patient with hypoperfusion requiring intervention (inotropics, 
vasopressors, or mechanical support) despite fluid resuscitation to restore 
perfusion. 
D- Worse: Patient similar to category C but worsening and unresponsive to 
initial interventions. 
E- Extreme: Includes cases where the futility of the treatment is evaluated 
and palliative treatment should be considered. 
In turn, all these categories are discriminated according to whether or not 
they have suffered cardiac arrest. 
In this work, patients with cardiogenic shock C, D and E will be considered as 
a group. It will be recorded if they have presented cardiac arrest. 
  
Inclusion criteria: 
 Patients of both sexes and older than 18 years, admitted to a coronary or 
polyvalent critical care unit, for an acute coronary syndrome with or without ST-
segment elevation who present with cardiogenic shock from admission or 
develop it during hospitalization and who can be followed up in its evolution until 
hospital discharge 
 
 
 
 
 
Exclusion criteria: 

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 Non-ischemic cardiogenic shock (chronic heart failure, myocarditis, sepsis, 
tachycardiomyopathy, Takotsubo, etc.). Cardiogenic shock A and B of the new 
SCAI classification. 
  
  
Information gathering: 
 The following variables will be analyzed: age, sex, risk factors and comorbidities, 
previous treatment, characteristics of the AMI that generated the shock, location 
of the infarction, Killip and Kimball on admission and evolution, time of evolution 
on admission, reperfusion strategies (fibrinolysis or angioplasty), if angioplasty 
was required: what type (primary, rescue, delayed), number of vessels operated, 
drug treatment instituted, hemodynamic monitoring and mechanical support 
(balloon pump, ECMO, mechanical ventilation, others). 
 The in-hospital evolution and eventual complications (fever, sepsis, COVID 19, 
multiorgan failure, arrhythmias, reinfarction, post-infarction angina, mechanical 
complications, transfusion requirement, major and minor bleeding) will be 
studied. Laboratory data will be collected upon admission and at 24 
hours. Hemodynamic measurements will be recorded at the time of Swan Ganz 
catheter placement and at 24 hours (if used) and echocardiogram data. The 
follow-up will only be in-hospital. 
 The data will be collected by the researchers from the different participating 
centers through an electronic file developed ad hoc in Red Cap and the data will 
be analyzed by the executive committee that will be made up of members of the 
research area of the Argentine Society of Cardiology. 
 The Red Cap platform is a secure web application for online data 
management. The data will be stored securely on a server at the Argentine 
Society of Cardiology. For centers without Internet access, it is possible to collect 
data offline through Red Cap using the Red Cap mobile application that is 
downloaded to a tablet or mobile device. With the app, data can be collected 
offline and then synced with Red Cap's server. While Attachment 1 can also be 
printed and used to collect data for subsequent electronic submission, direct 
collection of electronic data is preferable to avoid transcription errors. 
 As it is a study that involves different countries, the data will be analyzed 
globally and by country initially. Different sub-studies may be carried out with the 
information obtained. Each participating country has the right to submit ideas for 
conducting sub-studies. In that case, they must be formally presented to the 
Executive Committee, who will carry out the analysis and provide the data if the 
proposal is accepted. The sub-studies should be re-evaluated by the ethics 
committee. 
 Each participating Scientific Society will receive an Excel with the data of their 
country once the study is finished (anonymized data) that they can present at 
conferences or for publication as national experiences. Each participating center 

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will have available immediately statistical reports (automatically generated) of the 
patients who have entered their center. 
  
File in Red Cap: http://redcap.sac.org.ar/redcap/surveys/?s=RMCAYAXMF3 
  
Statistic analysis: 
 The information obtained will be incorporated into a database that will be 
analyzed using the statistical programs Epi-info and / or IBM SPSS. For each of 
the observed variables, a frequency table will be constructed. 
 Continuous variables will be expressed as mean and standard deviation for 
those with a normal or Gaussian distribution and as a median with an 
interquartile range 25% -75% for those without such distribution. The comparison 
between these variables will be carried out using the Student's t test or the 
Wilcoxon ranksum test, as appropriate. 
 Discrete variables will be expressed as percentages. Statistical comparisons 
between them will be made using the chi-square test with Yates correction or 
Fisher's exact test, as appropriate. 
 Contingency tables will be constructed to analyze the association or 
independence of the variables. The analysis of the existence of associations and 
/ or independent predictions between the different variables involved and the end 
points will be carried out by means of linear regression analysis and / or multiple 
logistic. The variables of univariate statistical significance will be entered for 
evaluation in the different regression models. The value corresponding to each 
covariate of the aforementioned analysis will be expressed as adjusted Odds 
Ratio and its corresponding 95% confidence interval. All statistical comparisons 
will be two-tailed, and p values <0.05 will be considered statistically significant. 
Consent of the patient 
 LATIN-Shock, as an observational study, only requires data that has already 
been collected and is available in the patient's medical record. It does not require 
sensitive data. It does not involve specific interventions and there is no follow-up 
after discharge, therefore, informed consent is not required. However, this could 
be adjusted according to local regulations of the participating countries. 
 
Ethical considerations 
 The protocol and the registration form will be submitted for approval by 
the ethics committee of the Sociedad Argentina de Cardiología, Azcuénaga 980, 
CABA. The study will be carried out in accordance with national and international 
ethical standards (CABA Law No. 3301, Declaration of Helsinki, and others). 
 As it is a descriptive study in which the data will be those normally collected in 
this pathology and there will be no identification of the patient or out-of-hospital 
follow-up, the signing of informed consent will not be required. 

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Study organization: 
  
Executive committee: 
Directors: Yanina Castillo Costa - Víctor Mauro 
Scientific and organizational secretariat: It is responsible for the organization of 
research, control, management and preparation of data analysis reports. It will be 
made up of: Heraldo D´Imperio, Mauro García Aurelio, Flavio Delfino. 
Each participating Latin American Society of Cardiology will be represented by 
one / two members (designated by its president) and they will be the ones who 
appear in the final document and receive the database of their country at the end 
of the study. 
Collaborators: This is the name given to the members of the centers where the 
inclusion of the participants takes place. The head of each center where the 
investigation is carried out and another doctor designated by him will be specially 
invited, who will be in charge of preparing the registration forms. 
  
Participating Centers: 
 Other Spanish-speaking Latin American Cardiology Societies will be invited to 
participate and they will designate the coronary units where the registry will be 
carried out. 
Sample: It is estimated to include approximately 500 patients in one year. 
 
Publications 
 The results of the study will be presented initially in the Congress of the 
Argentine Society of Cardiology and later in the different Congresses of 
Cardiology of the participating Societies. The publication will bear the names of 
all the researchers participating in the study and the members of the secretariat 
and the executive committee, who will be called the “LATIN Shock group”. 
 Individual centers and countries are encouraged to publish their results. 
 Each center coordinator is responsible for giving permission for the analysis, 
writing and publication of the individual LATIN Shock data. Site coordinators are 
requested to ensure that this data is not released prior to the release of the main 
LATIN Shock document. 
 LATIN SHOCK Principal Investigators are committed to ensuring that the main 
article is published in a timely manner (to facilitate the previous point). 
  

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 Bibliography 
 
1 AHA Scientific Statement. Invasive management of Acute Myocardial Infarction 
Complicated by Cardiogenic Shock. Circulation 2021; 143: 00-00. 
2 Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J et al. IABP-SHOCK 
II Trial Investigators. Intraaortic balloon support for myocardial infarction with 
cardiogenic shock. N Engl J Med . 2012; 367 : 1287-1296. doi: 10.1056 / 
NEJMoa1208410 . 
3 Menon V, Hochman J, Stebbins A, Pfisterer A, Col J, et al. Lack of progressin cardiogenic 
shock: lessons from the GUSTO trials. Eur HeartJ2000; 21: 1928-1936. 
4 Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S et al. Trends in 
incidence, management, and outcomes of cardiogenic shock complicating ST-elevation 
myocardial infarction in the United States. J Am Heart Assoc . 2014; 3 : e000590. doi: 
10.1161 / JAHA.113.000590. 
5 Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, et al. Early 
revascularization in acute myocardial infarction complicated by cardiogenic 
shock. NEnglMed. 1999; 341: 625-634 
6 Hochman JS, Buller CE, Sleeper LA, Boland J, Dzavik V, Sanborn TA, et al. Cardiogenic 
shock complicating acute myocardial infarction - etiologies, management and outcome: 
a report from the SHOCK Trial Registry. Should we emergently revascularize Occluded 
Coronaries for cardiog é nico shocK? JAmCollCardiol 2000 Sep; 36 (3SupplA): 1063-70. 
7 Rihal CH, Naidu S, Givertz MM, Szeto WY, Burke JA, Kap N et al. 2015SCAI / ACC / HFSA 
/ STS clinical expert consensus statement on the use of percutaneous mechanical 
circulatory support devices in cardiovascular care. Cathet. Cardiovasc. Intervent., 85: 
E175-E196.https: //doi.org/10.1002/ccd.25720.  
 
8 Castillo Costa Y, Garcia Aurelio M, Mauro V, Villareal R, Piombo A et al. Argentine 
National Registry of Cardiogenic Shock (ReNa-SHOCK). RevArgentCardiol 2016; 84: 228-
235. http://dx.doi.org/10.7775/rac.es.v84.i3.7825 
9 Zeymer U, Bueno H, Granger C, Hochman J, Huber k, and cols . Acute Cardiovascular 
Care Association position statement for the diagnosis and treatment of patients with 
acute myocardial infarction complicated by cardiogenic shock: A document of the Acute 
Cardiovascular Care Association of the European Society of Cardiology. European Heart 
Journal: Acute CardiovascularCare1–15. 
10 van Diepen S, Katz JN, Albert NF, Henry TD, Jacobs AK et al. Contemporary 
Management of Cardiogenic Shock: A Scientific Statement From the American Heart 
Association. Volume 136, Issue 16, 17 October 2017, Pages e232-e268 
11 Thiele H, AkinI, Sandri M, Fuernau G, de Waha S, Meyer-Sarae R. CULPRIT-SHOCK 
Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and 
Cardiogenic Shock. N Engl J Med 2017; 377: 2419-2432. DOI: 10.1056 / NEJMoa1710261 
12 Baran DA, Grines CL, Bailey S, et al. SCAI clinical expert consensus statement on the 
classification of cardiogenic shock: This document was endorsed by the American 
College of Cardiology (ACC), the American Heart Association (AHA), the Society of 

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Critical Care Medicine (SCCM), and the Society of Thoracic Surgeons (STS). Catheter 
Cardiovasc Inter2019; 94: 29–37