Clinical trial NCT03635840: The Effects of IABP Prior to Revascularization on Mortality of ACS Patients Complicated With Cardiogenic Shock
Official title: The Effects of Intra Aortic Balloon Pump Prior to Revascularization on Mortality of Patients With Acute Coronary Syndrome Complicated With Cardiogenic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiogenic Shock
Keywords: IABP
Cardiogenic Shock
Myocardial Infarction
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: National Cardiovascular Center Harapan Kita Hospital Indonesia
First posted: 2018-08-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 30-day-Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cradiovascular Center Harapan Kita Hospital
Study officials:
affiliation: National Cardiovascular Center Harapan Kita Hospital Indonesia
name: Dafsah Juzar, MD
role: PRINCIPAL_INVESTIGATOR
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