CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Intra Aortic Balloon Pumpdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03635840
NCT03635840N/ACompleted

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

Indonesia University·interventional·Posted Aug 17, 2018·Updated Mar 8, 2024

In Brief

A clinical study evaluating Intra Aortic Balloon Pump for Cardiogenic Shock. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 17, 2018
Enrollment StartJan 4, 2018
Primary CompletionApr 4, 2020
Study CompletionDec 4, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.9 years ago

Interventions

Intra Aortic Balloon Pumpdevice

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.