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

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ClinicalTrials.gov Identifier: NCT03635840
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Information provided by (Responsible Party):
Dafsah A. Juzar, MD, Indonesia University

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.


Condition or disease Intervention/treatment Phase
Cardiogenic Shock Device: Intra Aortic Balloon Pump Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Intra Aortic Balloon Pump Prior to Revascularization on Mortality of Patients With Acute Coronary Syndrome Complicated With Cardiogenic Shock
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : December 4, 2019
Estimated Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
No Intervention: Control
Group of patients not receiving IABP
Experimental: Intra Aortic Balloon Pump
Group of patients receiving Intra Aortic Balloon Pump prior to revascularization
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.

Other Name: IABP




Primary Outcome Measures :
  1. 30-day-Mortality [ Time Frame: 30 days ]
    Mortality of patients 30 day after hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635840


Contacts
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Contact: Dafsah Juzar, MD +621-5684093 ext 1265 djuzar@gmail.com
Contact: Arum Suryandari, MD +621-5684093 ext 1265 arumramadhyan@gmail.com

Locations
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Indonesia
National Cradiovascular Center Harapan Kita Hospital Recruiting
Jakarta, Indonesia, 11420
Contact: Dafsah Juzar, MD    +621-5684093 ext 1265    djuzar@gmail.com   
Contact: Gloria Kartika, MD    +621-5684093 ext 1265    gloria_kartika@yahoo.com   
Principal Investigator: Dafsah Juzar, MD         
Sponsors and Collaborators
Indonesia University
National Cardiovascular Center Harapan Kita Hospital Indonesia
Investigators
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Principal Investigator: Dafsah Juzar, MD National Cardiovascular Center Harapan Kita Hospital Indonesia
  Study Documents (Full-Text)

Documents provided by Dafsah A. Juzar, MD, Indonesia University:

Publications:

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Responsible Party: Dafsah A. Juzar, MD, Interventional Cardiologist, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03635840     History of Changes
Other Study ID Numbers: IABP18
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dafsah A. Juzar, MD, Indonesia University:
IABP
Cardiogenic Shock
Myocardial Infarction

Additional relevant MeSH terms:
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Shock
Shock, Cardiogenic
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases