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The study was terminated early due to a shortage of research and analytical personnel, which prevented the completion of the study as planned
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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
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Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abciximab IC bolus | Experimental | After CAG, For patients with undergoing percutaneous coronary intervention, intracoronary only or intravenous bolus abciximab(0.25mg/kg body weight) administration with intravenous bolus group has subsequent 12-hours continuous infusion at a dose 0.125ug/kg per minute (maximum: 10ug/min) |
|
| Abciximab IV bolus and 12hr continuous | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glycoprotein IIb/IIIa inhibitor (abciximab) | Drug | patients intracoronary bolus only group and intravenous bolus and 12-hours continuous infusion group bolus:0.25mg/kg body weight,continus 12hrs-0.125ug/kg per minute(maximum: 10ug/min) |
| Measure | Description | Time Frame |
|---|---|---|
| In cardiac MRI- infarct size (total late enhancement volume at day 3-7) | MRI: magnetic resonance image | day 3~7 after percutaneous coronary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc. | 1 month | |
| b. major bleeding : Hemoglobin 4 or more reduction, 2-unit If you need more than two RBC transfusions, intracranial or retroperitoneal bleeding, urgent operation for bleeding complication. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun-Jae Kang, Prof | Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital | Seoul | South Korea |
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RBC: red blood cell |
| 1 month |
| TIMI III flow count /myocardial blush score after PCI | TIMI: thrombolysis in myocardial infarction PCI: percutaneous coronary intervention | 1 day |
| At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index | LV: left ventricle | 1 week |
| Discharge, 1- month after comparing NT-proBNP | NT-proBNP : N-terminal pro-B-Type natriuretic peptide | 1 month |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000077284 | Abciximab |
| ID | Term |
|---|---|
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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