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| Name | Class |
|---|---|
| SIRIO MEDICINE | UNKNOWN |
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Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for treating acute ST-segment elevation myocardial infarction (STEMI). The main goals are to restore epicardial infarct-related artery patency and to achieve microvascular reperfusion as early as possible. No-reflow is the term used to describe inadequate myocardial perfusion of a given coronary segment without angiographic evidence of persistent mechanical obstruction of epicardial vessels and it refers to the high resistance of microvascular blood flow encountered during opening of the infarct-related coronary artery.
Despite optimal evidence-based PPCI, myocardial no-reflow can still occur, negating many of the benefits of restoring culprit vessel patency, and is associated with a worse in-hospital and long-term prognosis. Several strategies have been tested to revert the no-reflow including the use of thrombectomy, glycoprotein IIb/IIIa inhibitors and the use of intracoronary adenosine, but none has been demonstrated to effectively counteract the phenomenon.
The trial aims to show the effect of the administration of intracoronary adrenalin on myocardial reperfusion assessed by magnetic resonance in patients with STEMI undergoing PCI and with persistent coronary angiographic The Thrombolysis in Myocardial Infarction (TIMI) 0-1 flow during the interventional procedure after failure of standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| epinephrine | Active Comparator | intracoronary epinephrine is two ampoules each of 1:1000 epinephrine (1 μg/mL) diluted into 100 mL of normal saline (to 20 μg/mL epinephrine solution); a 5 ml syringe prepared will then contain 100 μg |
|
| no intracoronary epinephrine | Other | no epinephrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intracoronary epinephrine | Other | after failure of standard therapy patients will treated with epinephrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| myocardial infarct size (% total LV mass) | cMRI parameters: myocardial infarct size (% total LV mass) | 48-72 hours post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and extent of microvascular obstruction | cMRI parameter | 48-72 hours and 30 days post intervention |
| Myocardial salvage index (MSI) | cMRI parameter |
| Measure | Description | Time Frame |
|---|---|---|
| creatine kinase and troponin I release | 48-72 hours post intervention | |
| major cardiovascular events (MACE) | death, need for Target Lesion Revascularization, recurrent myocardial infarction (MI), new or worsening heart failure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eliano P Navarese, MD, PhD, FESC | Division of Cardiology, Pulmonary Disease and Vascular Medicine, Heinrich-Heine University Dusseldorf | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Pulmonary Disease and Vascular Medicine | Düsseldorf | 40225 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| no intracoronary epinephrine | Other | patients will receive standard therapy only |
|
| 48-72 hours and 30 days post intervention |
| Intra-myocardial haemorrhage (IMH) | cMRI parameter | 48-72 hours and 30 days post intervention |
| LV ejection fraction (LVEF) and volumes | cMRI parameter | 48-72 hours and 30 days post intervention |
| Thrombolysis in Myocardial Infarction (TIMI) flow grade) | Angiographic markers | 48-72 hours post intervention |
| Myocardial blush grade (MBG) | Angiographic markers | 48-72 hours post intervention |
| Computer-assisted myocardial blush quantification using the software 'Quantitative Blush Evaluator' (QuBE) | Angiographic markers | 48-72 hours post intervention |
| Degree of ST segment resolution on ECG | 48-72 hours post intervention |
| 30 days post intervention |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |