NCT05246683

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

December 26, 2021

Last Update Submit

February 15, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Find predictors of in-hospital mortality.

    1 year

  • To compare the clinical, management and evolution characteristics in the different participating Latin American countries.

    1 year

Study Arms (1)

cohort

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

Other: observational

Interventions

registry

cohort

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sociedad Argentina de Cardiologia

Buenos Aires, Buenos Aires F.D., C1115, Argentina

RECRUITING

MeSH Terms

Conditions

Shock, CardiogenicAcute Coronary Syndrome

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Victor M Mauro, md

    Sociedad Argentina de Cardiologia

    STUDY DIRECTOR

Central Study Contacts

Yanina B Castillo Costa, md

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2021

First Posted

February 18, 2022

Study Start

February 15, 2022

Primary Completion

December 18, 2022

Study Completion

December 18, 2022

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations