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Clinical Trials/NCT03635840
NCT03635840
Completed
N/A

The Effects of Intra Aortic Balloon Pump Prior to Revascularization on Mortality of Patients With Acute Coronary Syndrome Complicated With Cardiogenic Shock

Indonesia University1 site in 1 country34 target enrollmentJanuary 4, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiogenic Shock
Sponsor
Indonesia University
Enrollment
34
Locations
1
Primary Endpoint
30-day-Mortality
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Prevalence of cardiogenic shock in acute coronary syndrome patients is reported at about 5-8% with high fatality. Revascularization approach has already known as the standard of care, but the usage of intra-aortic balloon pump (IABP) as mechanical circulatory support is still a controversy. IABP SHOCK II trial revealed that short-term mortality did not improved by IABP but there are several essential variabels related to mortality that are not considered in the study which are IABP initiation time and weaning protocol.This study aim to evalute the effect of IABP prior to revascularization on mortality of patients with myocardial infarction complicated with shock.

92 subjects will be enrolled in this randomized controlled trial into two groups, with and without IABP. IABP group will be receiving the intervention prior to revascularization. The primary outcomes to be sought are in-hospital and 30-day mortality after revascularization. IABP effects measured by various indicators such as Global Longitudinal Strain by echocardiography on the 1st and 3rd day, NTproBNP and ST2 level on the 1st, 3rd and 5th day, effective lactate clearance and ureum creatinine level on the 1st and 3rd day and will be compared between two groups. Continous variabel will be presented in mean ± deviation standard or median, and analized with Student's t test or Mann-Whitney U test as appropriate.

Registry
clinicaltrials.gov
Start Date
January 4, 2018
End Date
December 4, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dafsah A. Juzar, MD

Interventional Cardiologist, Principal Investigator

Indonesia University

Eligibility Criteria

Inclusion Criteria

  • Age greater than 18 years old
  • Myocardial infarction patients complicated with shock
  • Willing to enroll in the study (signed consent)

Exclusion Criteria

  • Age greater than 80 years old
  • Heart and lung resuscitation for more than 30 minutes
  • Cardiogenic shock onset \>12 hours (if known) or \>18 hours (if not known/patient presented in emergency department already with shock)
  • Mechanical complication of myocardial infarction
  • Moderate and severe aorta regurgitation
  • Peripheral artery disease making IABP unfeasible
  • Patients not receiving revascularization by percutaneous coronary intervention
  • Patients who died before IABP insertion
  • Care termination requested by family

Outcomes

Primary Outcomes

30-day-Mortality

Time Frame: 30 days

Mortality of patients 30 day after hospitalization

Study Sites (1)

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