The Effects of Intra Aortic Balloon Pump Prior to Revascularization on Mortality of Patients With Acute Coronary Syndrome Complicated With Cardiogenic Shock
Phase: NA
Conditions: Cardiogenic Shock
Sponsor: Indonesia University

 
 
The Effects of Intra Aortic Balloon Pump Prior to 
Revascularization on Mortality of Myocardial Infarction 
Patients Complicated With Shock 
 
 
 
Date: 4th Januari 2018 
 
 
 
Dafsah A. Juzar, MD, FIHA, FESC, FAPSIC, FAsCC 
 

 
 
Study Protocol 
Title 
Principal Investigator 
Dafsah A. Juzar, MD 
National Cardiovascular Center Harapan Kita Hospital, Indonesia 
Sponsor 
Indonesia University  
Aim 
To observe the effects of intra aortoc balloon pump prior to revascularization on mortality 
of myocardial infarction patients complicated with shock 
Study Design 
Randomized clinical trial. 
Anticipated Outcome 
Intra aortic balloon pump insertion prior to revascularization will improve mortality rate 
of myocardial infarction patients complicated with shock. 
Inclusion and Exclusion Criteria 
Inclusion Criteria 
1. Age over 18 years and less than 75 years 
2. Myocardial infarction patients complicated with shock 
3. Agree to participate in the study (signed consent) 
Exclusion Criteria 
1. Age over 80 years 
2. Cardio pulmonary resuscitation for more than 30 minutes 
3. Shock onset > 12 hours (if onset time is clearly known) and > 18 hours (if the 
exact time of shock onset is unknown or patient presented with shock on 
admission) 
4. Mechanical complication of myocardial infarction 
5. Moderate and severe aortic regurgitation 
6. No revascularization treatment (PCI) is done 
7. Patient dies prior to intra aortic balloon pump insertion 
 
Withdrawal or Discontinuation Criteria 
1. Treatment termination requested by family 
Procedures 
1. Patients who meet the criteria and agree to participate on the study were taken as 
research subjects. Patients with myocardial infarction with shock complications who 
do not meet the criteria will continue to be recorded for registry. 
2. Patients will be treated according  to standard shock guideline,  with peripheral oxygen 
saturation target > 92% and mean arterial pressure ≥65 mmHg. Inotropic 
administration is based on physicians discretion with dobutamine and norepinephrine 
The Effects of Intra Aortic Balloon Pump Prior to Revascularization on Mortality of 
Myocardial Infarction Patients Complicated With Shock 

 
 
as the drug of choice. 
3. Patients will be randomized into two groups, control and treatment group (group of 
subjects receiving IABP). 
4. Anamnesis, physical examination (including vital signs) and electrocardiography, 
echocardiography, laboratory assessment will be performed. 
5. Non-invasive hemodynamic examination with echocardiogram will be performed 
(Global Longitudinal Strain data will be recorded) and will also be repeated on the 3rd 
day of hospitalization. 
6. Peripheral venous blood samples taken as many as 5 cc at the time of admission for 
basic laboratory profile such as routine blood assessments (hemoglobin, hematocrit, 
leucocytes, platelets), blood glucose, CKMB, hs-Troponin, SGOT, SPGT, urea, 
creatinine. 
7. Peripheral venous blood samples of 3 cc were taken at the 0th hour or the 1st day of 
admission, at 48th hour (3rd day) and 96th hour (5th day) for serum creatinine, NT -
proBNP and sST2 assessment. 
8. Peripheral arterial blood samples of 3 cc were taken at the 0th hour and the 12th hour 
of admission for lactate level assessment. 
9. IABP insertion will be performed on IABP group, as early as possible either bedside 
or in the catheterization room before revascularization. IABP insertion is done through 
a communist femoral artery with or without a sheath, according to the operator's 
assessment. The timing of IABP initiation will be recorded. 
10.  Revascularization will be performed on all patients with the target time from 
randomization to coronary intervention is two hour. 
11. After percutaneous revascularization is performed, the patient is transferred to the 
intensive care unit and the secondary prophylactic medication for coronary artery 
disease was administered to both groups according to the standard of medical care. 
12. The patient will be continously monitored. Records were made on in hospital mortality 
and 30 days after the revascularization. 
Analysis Method  
Data will be analyzed using SPSS 16.0 software program with appropriate statistical test. A 
two-way p value <0.05 is considered as statistically significant. Categorical variables are 
reported as frequency and percentage. The data will be analyzed using Fisher test or χ2. 
After assessing the normality of the data distribution with the Kolmogorov-Smirnov 
normality test, continuous variables will be presented in the mean ± standard deviation 
(SD) or median, and analyzed according to the normality of the distribution by Student's t 
or Mann-Whitney U test. 
Treatment Duration 
During hospitalization 
Primary Outcome 
In-hospital mortality and 30-day-after-revascularization mortality. 
 
 

 
 
SUBJECT INFORMATION AND CONSENT FORM 
 
The study aim to observe the effect of Intra Aortic Ballon Pump (IABP) prior to 
revascularization in myocardial infarction patients complicated with shock in National 
Cardiovascular Center Harapan Kita Hospital.  92 individuals will be enrolled in the study.  
 
A. Participation in the research 
You are free to participate in this study without any coercion. Once you have decided to 
participate, you are also free to resign / change your mind at any time without any 
penalty or sanction. If you refuse to participate then the patient will still be treated 
according to hospital procedures. 
 
B. Research Procedures 
1. Patient personal data and history will be taken: name, age, history of disease, smoking 
and family history. 
2. Physical examination will be performed to obtain vital signs and urine production. 
Electrocardiography will also be performed. 
3. All patients will be receiving treatment according to guidelines. 
4. On the day of admission, peripheral blood sampling will be done and 
echocardiography examination will also be performed to determine the patient's 
hemodynamic status. 
5. If the patient is receiving IABP, the insertion will be done by an interventionalist prior 
to revascularization. 
6. At 12 hours after the admission, arterial blood sampling will be done for as much as 3 
ml. 
7. On the 3rd day of hospitalisation, peripheral blood sampling will be done for as much 
as 6 ml and echocardiography examination will also be performed for the second time. 
8. On the 5th day of hospitalisation, peripheral blood sampling will be done for as much 
as 3 ml. 
9. The patient's condition and progress will be monitored during hospitalization. 
 
C. Risks and Side Effects 
Complications that may occur in the intra-aortic balloon pump insertion including blood 
vessel-related complications such as angio-ischemia, thrombocytopenia, infection, 
tearing of the aortic vessels, renal failure, neurological disorders, and bleeding. Studies 
show a complication of limb ischemia of less than 1%. Bleeding occurred in 0.8% of 
cases. If acute limb ischemia is occured, duplex evaluation and the removal of intra-
aortic balloon pump will be done continued with fibrinolytic therapy or thrombus 
transcatheter aspiration. 
 
 
 
 

 
 
D. Benefits 
This study will prove the benefit of the intra-aortic balloon pump prior to 
revascularization in improving the prognosis of cardiogenic shock patients, therefore 
increase the life expectancy of myocardial infarction patients complicated with shock. 
 
E. Confidentiality 
All information relating to the study will be kept confidential and will be known only to 
researchers and research staff. The results of the study will be published without the 
identity of the study subjects. 
 
F. Financing 
All research related costs will be borne by researchers and National Cardiovascular 
Center Harapan Kita Hospital. 
 
G. Additional Information 
If at any time further explanations are needed, you can contact Dafsah A. Juzar, MD at 
ICVCU 
National 
Cardiovascular 
Center 
Harapan 
Kita 
Hospital. 
You can also inquire the information about the research from the Research Ethics 
Committee of National Cardiovascular Center Harapan Kita Hospital, Phone +62-
5681111, ext. 2837/2831 or email: irb.kometik_rsjpdhk@gmail.com. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
SUBJECT INFORMATION AND CONSENT FORM 
 
Name 
 
: 
Age 
 
: 
Gender 
 
: 
Address 
 
: 
ID number   
: 
 
As myself / husband / wife / child / parent / sibling * of: 
Name 
: 
Date of birth  : 
Gender 
 
: 
Address 
 
: 
 
 
With this stated AGREE to participate in the study. The purpose, nature, benefits of this 
study, and the risks it may cause has been adequately explained by the physician / researcher 
and 
I 
have 
fully 
understood. 
This consent I make with full consciousness and without coercion. 
 
Signature : _________________ 
 
Date  
: _________________ 
 
*cross the unnecessary ones