NCT03635840

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DEVICE	Intra Aortic Balloon Pump	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.

Timeline

• Start date: 2018-01-04
• Primary completion: 2020-04-04
• Completion: 2020-12-04
• First posted: 2018-08-17
• Last updated: 2024-03-08

Locations

1 site across 1 country: Indonesia