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

NCT ID: NCT05246683

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2022-12-18

Brief Summary

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.

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.

Conditions

Cardiogenic Shock; Acute Coronary Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

cohort

Observational evaluation during the hospital stage on diagnosis, treatment and evolution of patients with cardiogenic shock.

observational

Intervention Type: OTHER

registry

Interventions

observational

registry

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Argentina de Cardiología

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor M Mauro, md

Role: STUDY_DIRECTOR

Sociedad Argentina de Cardiologia

Locations

Sociedad Argentina de Cardiologia

Buenos Aires, Buenos Aires F.D., Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Yanina B Castillo Costa, md

Role: CONTACT

yanu_c@hotmail.com

00541141975459

Flavio A Delfino, md

Role: CONTACT

flavioandresdelfino@gmail.com

00541168665399

Facility Contacts

Yanina B Castillo Costa, md

Role: primary

yanu_c@hotmail.com

0054 11 14975459

Victor M Mauro, md

Role: backup

victormauro@uolsinectis.com.ar

00541144016567

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LATIN SHOCK

Identifier Type: -

Identifier Source: org_study_id