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| Name | Class |
|---|---|
| National Cardiovascular Center Harapan Kita Hospital Indonesia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day-Mortality | Mortality of patients 30 day after hospitalization | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dafsah Juzar, MD | National Cardiovascular Center Harapan Kita Hospital Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cradiovascular Center Harapan Kita Hospital | Jakarta | 11420 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22216842 | Background | Nabel EG, Braunwald E. A tale of coronary artery disease and myocardial infarction. N Engl J Med. 2012 Jan 5;366(1):54-63. doi: 10.1056/NEJMra1112570. No abstract available. | |
| 12590903 | Background | Lindholm MG, Kober L, Boesgaard S, Torp-Pedersen C, Aldershvile J; Trandolapril Cardiac Evaluation study group. Cardiogenic shock complicating acute myocardial infarction; prognostic impact of early and late shock development. Eur Heart J. 2003 Feb;24(3):258-65. doi: 10.1016/s0195-668x(02)00429-3. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 4, 2018 | Aug 14, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D007423 | Intra-Aortic Balloon Pumping |
| ID | Term |
|---|---|
| D015908 | Counterpulsation |
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |