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The investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin.
Mechanical reperfusion for acute myocardial infarction (AMI) targets optimal revascularization of the epicardial artery but also aims at improved myocardial salvage. The goal of reperfusion therapies has shifted to include reperfusion downstream at the level of capillary bed, and it might be more appropriate that the hypothesis now be termed "the time dependent open artery and open microvascular hypothesis." Failure to achieve myocardial reperfusion despite the presence of a patent coronary artery has been termed the "no-reflow" phenomenon and attributed to microvascular dysfunction. It has become apparent that clinical outcomes are not only associated with patency of the epicardial artery, but also with patency of the microcirculation. Persistent impairment of microcirculation is associated with poor clinical outcome. Complete reperfusion in AMI settings necessitates reopening of the all consecutive vascular compartments all the way through the coronary circulation. But, embolization following percutaneous coronary intervention (PCI) and in situ microthrombi generation at the microvascular level makes this goal difficult to achieve. For this reason, mechanical intervention to the epicardial coronary artery with or without using distal protection wouldn't be enough to achieve ideal reperfusion at the ultimate (microvascular) level. At this point, it has become more evident that we need to develop more competent and feasible reperfusion strategies which can help us to achieve reperfusion as complete as possible at all levels.
Hypothesis:
Complementary intracoronary streptokinase administration to primary PCI may provide further improvement in myocardial perfusion by dissolving microvascular thrombus [in situ formed or embolized from proximal site (spontaneous or following PCI)] and fibrin. Improvement in microvascular perfusion may translate into reduction in infarct size and improvement in left ventricular function at long term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Following standard primary percutaneous coronary intervention for ST elevation acute myocardial infarction 250.000 U intracoronary Streptokinase will be given |
|
| 2 | Active Comparator | Standard percutaneous coronary intervention for ST elevation myocardial infarction will be performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intracoronary infusion, | Drug | streptokinase, 250,000 units |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary end points defined as the indices of the microvascular perfusion which is going to be assessed on day 2 (48 hours after the primary PCI)and infarct size at 6 months. | 6 months | |
| Index of microvascular resistance, | 48 hours | |
| Coronary flow reserve | 48 hours | |
| Left ventricular infarct size by SPECT at six months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Death | 1 year | |
| Reinfarction | 1 month | |
| Major bleeding |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murat Sezer, M.D. | Istanbul University, Istanbul School of Medicine | Study Director |
| Sabahattin Umman, Prof. | Istanbul University, Istanbul School of Medicine | Principal Investigator |
| Taner Goren, Prof. | Istanbul University, Istanbul School of Medicine | Study Chair |
| Huseyin Oflaz, Assoc.Prof. | Istanbul University, Istanbul School of Medicine | Study Chair |
| Irem Okcular, M.D. | Istanbul University, Istanbul School of Medicine | Study Chair |
| Yılmaz Nisanci, Prof. | Istanbul University, Istanbul School of Medicine | Study Chair |
| Berrin Umman, Prof. | Istanbul University, Istanbul School of Medicine | Study Chair |
| Ahmet K Bilge, M.D. | Istanbul University, Istanbul School of Medicine | Study Chair |
| Mehmet Meric, Prof. | Istanbul University, Istanbul School of Medicine |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University, Istanbul School of Medicine, Department of Cardiology | Istanbul | 34290 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19744615 | Derived | Sezer M, Cimen A, Aslanger E, Elitok A, Umman B, Bugra Z, Yormaz E, Turkmen C, Adalet IS, Nisanci Y, Umman S. Effect of intracoronary streptokinase administered immediately after primary percutaneous coronary intervention on long-term left ventricular infarct size, volumes, and function. J Am Coll Cardiol. 2009 Sep 15;54(12):1065-71. doi: 10.1016/j.jacc.2009.04.083. | |
| 17476008 |
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| primary percutaneous coronary angioplasty | Procedure |
|
| during hospitalization |
| Sezer M, Oflaz H, Goren T, Okcular I, Umman B, Nisanci Y, Bilge AK, Sanli Y, Meric M, Umman S. Intracoronary streptokinase after primary percutaneous coronary intervention. N Engl J Med. 2007 May 3;356(18):1823-34. doi: 10.1056/NEJMoa054374. |
| ID | Term |
|---|---|
| D013300 | Streptokinase |
| ID | Term |
|---|---|
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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