LATIN SHOCK: Latin American Registry of Cardiogenic Shock in the Context of Acute Coronary Syndrome (LATIN-SHOCK)

LATIN SHOCK: Registro Latinoamericano de Shock Cardiogénico en el Contexto de Los Sindromes Coronarios Agudos

This is a Registry of the characteristics and clinical evolution of patients admitted for acute coronary syndromes (with or without st segment elevation) who present with cardiogenic shock or develop it during the hospitalization period.

Cardiogenic shock is a rare pathology, but it constitutes the leading cause of mortality in patients hospitalized for acute infarction myocardium. Its incidence ranges between 7 and 10% of the cases of infarction1 and is associated with a mortality of 40-50% despite revascularization and the use of Intra-Aortic Counterpulsation Balloon. Most of the bibliography on this subject is North American and has a lot of years and the one currently published shows mostly the results of different ventricular supports that are not used routinely in our countries. So far there is no record that reports the reality of Latin America. Only in Argentina, a registry has been carried out (Re Na Shock) but more than 5 years have passed since its publication. In the last years have even changed the management guidelines for this pathology and have been published works that could have changed previous behaviors

. This is a project of the Argentine Society of Cardiology to collect data epidemiological and current management of cardiogenic shock in Latin America.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Cardiogenic Shock
• Intervention / Treatment: Other: observational

Detailed Description

It is an international, multicenter, observational registry of prospective and consecutive patients with cardiogenic shock in the context of acute coronary syndromes, which will last 12 months from its start on December 4, 2021. Coronary Units will be invited to participate from different Latin American countries through the different cardiology societies. It will be assigned to each country and each participant center a number and patients will be entered into the registry in correlative order by center (1-2-3-etc) to maintain the confidentiality of the patients data. Since the patient data will be extracted from the medical records, the records will be anonymous and there will be no follow-up, no informed consent is required. The names of the participating centers of 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 mm Hg, 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 (SCAI), which includes 5 categories. In this work, patients with cardiogenic shock only those with C, D and E letter will be included.

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Yanina B Castillo Costa, md; Phone Number: 00541141975459; Email: yanu_c@hotmail.com
• Study Contact Backup: Name: Flavio A Delfino, md; Phone Number: 00541168665399; Email: flavioandresdelfino@gmail.com

Study Locations

• Argentina
  • Caba
    • Buenos Aires, Caba, Argentina, C1115
      • Recruiting
      • Sociedad Argentina de Cardiología
      • Contact: Yanina B Castillo Costa, md; Phone Number: 0054 11 14975459; Email: yanu_c@hotmail.com
      • Contact: Victor M Mauro, md; Phone Number: 00541144016567; Email: victormauro@uolsinectis.com.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with acute cardiac syndrome with or without st elevation and cardiogenic shock as a complication. Includes cardiogenic shock at presentation or during hospitalario period

Description

Inclusion Criteria:Patients of both sexes and older than 18 years, admitted to the unit coronary or polyvalent critical care, for an acute coronary syndrome with or without ST-segment elevation presenting cardiogenic shock from the admission or develop it during the hospitalization and that can be followed in its evolution until hospital discharge. -

Exclusion Criteria:Non-ischemic cardiogenic shock (chronic heart failure, myocarditis, sepsis, tachycardiomyopathies, Takotsubo, etc.). Cardiogenic shock A and B of the new SCAI classification

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cohort; Observational evaluation during the hospital stage on diagnosis, treatment and evolution of patients with cardiogenic shock.	Other: observational; registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Register through the survey modality the incidence of the clinical characteristics of the patients admitted to the coronary unit with acute coronary syndromes and cardiogenic shock, either from admission or during its in-hospital evolution.	characteristics	1 year
To analyze the treatment and diagnostics methods of patients with cardiogenic shock during hospital stay.	treatment	1 year
Observe in-hospital clinical evolution and incidence of complications of patients with cardiogenic shock.	evolution	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Find predictors of in-hospital mortality.	predictors	1 year
To compare the clinical, management and evolution characteristics in the different participating Latin American countries.	compare	1 year

Collaborators and Investigators

• Sponsor: Sociedad Argentina de Cardiología
• Investigators: Study Director: Victor M Mauro, md, Sociedad Argentina de Cardiología

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Anticipated): December 18, 2022
• Study Completion (Anticipated): December 18, 2022

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Myocardial Infarction; Infarction; Syndrome; Shock; Acute Coronary Syndrome; Shock, Cardiogenic
• Other Study ID Numbers: LATIN SHOCK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No