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The Effect of IABP Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome

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ClinicalTrials.gov Identifier: NCT03638609
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Information provided by (Responsible Party):
Isman Firdaus, MD, Indonesia University

Brief Summary:

The prevalence of cardiac arrests is still high worldwide. Despite the return of spontaneous circulation (ROSC), mortality and morbidity in post cardiac arrest patients is reported high. Comprehensive management is essential in treating patients with post cardiac arrest syndrome. Adequate circulatory stability is achieved with fluid therapy, vasoactive drug therapy, and consideration of mechanical support. Intra-Aortic Ballon Pump (IABP) is one of the most feasible and available mechanical support in developing countries including Indonesia.

There are several benefits of IABP reported in acute myocardial infarction complicated with cardiogenic shock. Nevertheless, the IABP-SHOCK II study revealed contradictive result which is IABP support was not improving mortality in acute myocardial infarction complicated with cardiogenic shock after revascularization. Other study, Korean Acute Myocardial Infarction Registry (KAMIR), also reported no benefits of IABP support in cardiogenic shock patients. But, the study the investigators mentioned earlier is a registry study, attributed to selection bias and several confounding factors resulting mismatch in population. There are no consideration to IABP time of initiation and duration of use in both studies.

The Investigator is aiming to prove the early insertion of IABP to a better outcome compared with the absence of early IABP. The objective of the study is to assess mortality in post cardiac arrest syndrome patients with early insertion of IABP support. A total of 102 subjects will be enrolled in this study, divided into IABP and non-IABP group. The primary outcome is in-hopital-mortality, and various indicators in the pathomechanisme of post cardiac arrest syndrome will be measured in 30 minutes and 6 hours after ROSC. Effective lactate clearance, IL-6, Beclin-1, Caspase-3, a-vO2 diff, and ScvO2, cardiac output, VTI, TAPSE and ejection fraction will be measured and analized between the two groups.


Condition or disease Intervention/treatment Phase
Post-Cardiac Arrest Syndrome Device: Intra Aortic Balloon Pump Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Intra Aortic Balloon Pump Early Insertion on Mortality in Post Cardiac Arrest Patients With Acute Coronary Syndrome
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : October 23, 2018
Estimated Study Completion Date : November 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

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 in 3 hours after ROSC (early insertion of IABP)
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. In-Hospital Mortality [ Time Frame: 30 days ]
    Mortality of patients during the hospitalization receiving early insertion IABP



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than 18 and less than 75 years.
  2. Post cardiac arrest syndrome patients with decreased level of consciousness (cerebral performance categories (CPC) more than 1) and hypotension (systolic blood pressure less than 100)
  3. Experiencing successful cardiac rescucitation following cardiac arrest

Exclusion Criteria:

  1. History of stroke (based on interview)
  2. Unequal pupil
  3. Previous use of IABP
  4. Aorta regurgitation
  5. Brugada syndrome and congenital long QT

Drop-out Criteria:

  1. Participants who died before IABP insertion
  2. The family requests for a termination of treatment.
  3. Anemia caused by bleeding with hemoglobin decrement by >3 gr/dL
  4. Ankle brachial index(ABI) less than 0,8

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): NCT03638609


Contacts
Contact: Isman Firdaus, MD +621-5684093 ext 1265 ismanf@yahoo.com
Contact: Arum Suryandari, MD +621-5684093 ext 1265 arumramadhyan@gmail.com

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

Documents provided by Isman Firdaus, MD, Indonesia University:

Publications:
Neumar RW, Nolan JP, Adrie C, Aibiki M, Berg RA, Böttiger BW, Callaway C, Clark RS, Geocadin RG, Jauch EC, Kern KB, Laurent I, Longstreth WT Jr, Merchant RM, Morley P, Morrison LJ, Nadkarni V, Peberdy MA, Rivers EP, Rodriguez-Nunez A, Sellke FW, Spaulding C, Sunde K, Vanden Hoek T. Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. A consensus statement from the International Liaison Committee on Resuscitation (American Heart Association, Australian and New Zealand Council on Resuscitation, European Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Asia, and the Resuscitation Council of Southern Africa); the American Heart Association Emergency Cardiovascular Care Committee; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiopulmonary, Perioperative, and Critical Care; the Council on Clinical Cardiology; and the Stroke Council. Circulation. 2008 Dec 2;118(23):2452-83. doi: 10.1161/CIRCULATIONAHA.108.190652. Epub 2008 Oct 23.
Firdaus I. Registry of Acute and Intensive Cardiovascular Care on Outcome (RAICOM) in National Cardiovascular Center Harapan Kita Indonesia. 2016.
iSTEMI (Indonesia STEMI). 2016

Responsible Party: Isman Firdaus, MD, Interventional Cardiologist, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03638609     History of Changes
Other Study ID Numbers: IABP17
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Isman Firdaus, MD, Indonesia University:
IABP
Post-Cardiac Arrest Syndrome
Beclin-1
Caspase-3
Mortality

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Heart Arrest
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases