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

NCT03635840 | Completed

• 1 other identifier: IABP18
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock

Keywords

IABP; Cardiogenic Shock; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 30-day-Mortality

  Mortality of patients 30 day after hospitalization

  30 days

Study Arms (2)

Control

NO INTERVENTION

Group of patients not receiving IABP

Intra Aortic Balloon Pump

EXPERIMENTAL

Group of patients receiving Intra Aortic Balloon Pump prior to revascularization

Device: Intra Aortic Balloon Pump

Interventions

Intra Aortic Balloon Pump DEVICE

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.

Also known as: IABP

Intra Aortic Balloon Pump

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years old
• Myocardial infarction patients complicated with shock
• Willing to enroll in the study (signed consent)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• National Cardiovascular Center Harapan Kita Hospital Indonesia: collaborator

Study Sites (1)

National Cradiovascular Center Harapan Kita Hospital

Jakarta, 11420, Indonesia

Location

Related Publications (21)

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  PMID: 11376306 BACKGROUND

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  PMID: 24105878 BACKGROUND

• Hochman JS, Sleeper LA, Webb JG, Dzavik V, Buller CE, Aylward P, Col J, White HD; SHOCK Investigators. Early revascularization and long-term survival in cardiogenic shock complicating acute myocardial infarction. JAMA. 2006 Jun 7;295(21):2511-5. doi: 10.1001/jama.295.21.2511.

  PMID: 16757723 BACKGROUND

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  PMID: 18250279 BACKGROUND

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  PMID: 18765387 BACKGROUND

• Abraham WT, Adams KF, Fonarow GC, Costanzo MR, Berkowitz RL, LeJemtel TH, Cheng ML, Wynne J; ADHERE Scientific Advisory Committee and Investigators; ADHERE Study Group. In-hospital mortality in patients with acute decompensated heart failure requiring intravenous vasoactive medications: an analysis from the Acute Decompensated Heart Failure National Registry (ADHERE). J Am Coll Cardiol. 2005 Jul 5;46(1):57-64. doi: 10.1016/j.jacc.2005.03.051.

  PMID: 15992636 BACKGROUND

• Brodie BR, Stuckey TD, Hansen C, Muncy D. Intra-aortic balloon counterpulsation before primary percutaneous transluminal coronary angioplasty reduces catheterization laboratory events in high-risk patients with acute myocardial infarction. Am J Cardiol. 1999 Jul 1;84(1):18-23. doi: 10.1016/s0002-9149(99)00185-x.

  PMID: 10404845 BACKGROUND

• Sjauw KD, Engstrom AE, Vis MM, van der Schaaf RJ, Baan J Jr, Koch KT, de Winter RJ, Piek JJ, Tijssen JG, Henriques JP. A systematic review and meta-analysis of intra-aortic balloon pump therapy in ST-elevation myocardial infarction: should we change the guidelines? Eur Heart J. 2009 Feb;30(4):459-68. doi: 10.1093/eurheartj/ehn602. Epub 2009 Jan 23.

  PMID: 19168529 BACKGROUND

• Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.

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• Fuernau G, Poenisch C, Eitel I, Denks D, de Waha S, Poss J, Heine GH, Desch S, Schuler G, Adams V, Werdan K, Zeymer U, Thiele H. Prognostic impact of established and novel renal function biomarkers in myocardial infarction with cardiogenic shock: A biomarker substudy of the IABP-SHOCK II-trial. Int J Cardiol. 2015 Jul 15;191:159-66. doi: 10.1016/j.ijcard.2015.04.242. Epub 2015 May 1.

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  PMID: 24062898 BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic; Myocardial Infarction

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Study Officials

• Dafsah Juzar, MD

  National Cardiovascular Center Harapan Kita Hospital Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist, Principal Investigator

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: January 4, 2018
• Primary Completion: April 4, 2020
• Study Completion: December 4, 2020
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

ID (1)