The Effects of IABP Prior to Revascularization on Mortality of ACS Patients Complicated With Cardiogenic Shock

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Device: Intra Aortic Balloon Pump


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Group of patients not receiving IABP | |
| Experimental: Intra Aortic Balloon Pump<br>Group of patients receiving Intra Aortic Balloon Pump prior to revascularization | Device: Intra Aortic Balloon Pump<br>* Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle. It is indicated as supportive therapy for patients undergoing revascularization, cardiogenic shock and mechanical complication. Balloon dilatation during dyastolic phase increasing dyastolic pressure in aorta, improving coronary vascularization and myocardial oxygen supply. In systolic phase, the balloon deflates, reducing the left ventricle afterload hence decreasing myocardial oxygen demand.<br>* Other names: IABP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day-Mortality | Mortality of patients 30 day after hospitalization | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IABP, Cardiogenic Shock, Myocardial Infarction