EPOMI (erythropoietin in myocardial infarction): a multicenter randomized trial evaluating the effect of an erythropoietin injection in the acute phase of myocardial infarction on scar size and left ventricular remodeling

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Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Trade Name: NeoRecormon Product Name: Epoetin beta Pharmaceutical Form: Solution for injection CONDITION: Myocardial infarction, acute coronary syndrome with ST-segment elevation PRIMARY OUTCOME: Main Objective: The primary objective is to determine whether an injection of 1000 IU/kg of EPO immediately following revascularization angioplasty performed within the first 6 hours of an acute coronary syndrome with ST-segment elevation reduces the size of the infarct at three months. Primary endpoint(s): Primary endpoint: The size of myocardial necrosis measured by late gadolinium enhancement cardiac MRI at 3 months post-infarction; • MRI performed within 5 (+ or - 2) days and then at 3 months to analyze left ventricular volumes, contractile function, myocardial perfusion, and scar size; Blood samples taken on days 0, 1, 2, 3, and 10 for monitoring of complete blood count, platelets, and reticulocytes; Cytokine and circulating microparticle levels scheduled for days 0, 1, 2, and 3; Clinical follow-up performed during the routine 3-month consultation; Collection of cardiovascular events at 1 year via telephone contact; Secondary Objective: - Evaluate post-infarction left ventricular remodeling; - Evaluate the rate of major post-infarction cardiovascular events; - Evaluate changes in blood levels of hemoglobin, hematocrit, reticulocytes, cytokines and pro-angiogenic cell progenitors, and circulating microparticles with potential effects on coronary vasomotor tone and platelet aggregation; INCLUSION CRITERIA: Selection criteria: • Male or female patients over 18 years of age • Social Security coverage • Weight between 50 and 110 kg • Acute coronary syndrome with persistent ST-segment elevation defined by: 1) typical angina pain > 30 minutes, 2) ST-segment elevation > 0.1 mV (peripheral leads and V5-V6) or > 0.2 mV (precordial leads V1 to V4) in at least 2 contiguous leads • Time between symptom onset and reperfusion: 6 hours • Treatment by primary angioplasty Inclusion criteria (to be assessed immediately after angioplasty) • Successful recanalization of the culprit artery (residual stenosis: 50%, TIMI flow 2 or 3) Artery of infarction: Proximal circumflex (segment 11, dominant circumflex), proximal and middle LAD (segments 6 and 7), and 1st, 2nd, and 3rd segments of the right coronary artery (segments 1, 2, 3)? Implantation technique possible.
Epistemonikos ID: 1b7b6b9750bca612c6c9bade18be78c8b8d2b713
First added on: Aug 21, 2024
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