Ignite Creation Date:
2024-05-06 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03635840
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2018-08-15
Brief Title:
The Effects of IABP Prior to Revascularization on Mortality of ACS Patients Complicated With Cardiogenic Shock
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
The Effects of Intra Aortic Balloon Pump Prior to Revascularization on Mortality of Patients With Acute Coronary Syndrome Complicated With Cardiogenic Shock
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 protocolThis 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 Students t test or Mann-Whitney U test as appropriate
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 Students t test or Mann-Whitney U test as appropriate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None