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

University of Indonesia (UI)

Status

Completed

Conditions

Cardiogenic Shock

Treatments

Device: Intra Aortic Balloon Pump

Study type

Interventional

Funder types

Other

Identifiers

NCT03635840

IABP18

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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