postconditioning during coronary angioplasty in acute myocardial infarction study

Conditions: Myocardial Reperfusion Injury

Summary: the post-conditioning during coronary angioplasty in acute myocardial infarction (post-ami) trial will evaluate the usefulness of postconditioning in limiting infarct size and microvascular damage during the early and late phases after ami.

post-ami is a single-center, prospective, randomized trial, with a planned inclusion of 78 patients with st-elevation acute myocardial infarction (ami). patients will be randomly assigned to postconditioning arm (primary angioplasty (pa) and stenting followed by brief episodes of ischemia-reperfusion performed during the first minutes of reperfusion) or non-postconditioning arm (pa and stenting without additional intervention). all patients will be treated medically according to current international guidelines, including glycoprotein iib/iiia inhibitors before pci. the primary end point is to evaluate whether postconditioning, compared to pa without additional intervention, reduces infarct size estimated by magnetic resonance at 30±10 days after the ami. secondary end points are microvascular obstruction observed at magnetic resonance, st-segment elevation resolution, persistent st-segment elevation, angiographic myocardial blush grade \<2 and non sustained/sustained ventricular tachycardia in the 48 hours following pa. further secondary end points are enzymatic infarct size, left ventricular remodeling and left ventricular function at magnetic resonance performed at 6±1 months, and the reduction of major adverse cardiac events at 30 days and 6 months.

Eligibility criteria:
inclusion criteria: * clinical evidence of myocardial infarction defined by the presence of ischemic chest pain lasting more than 30 minutes, with a time interval from the onset of symptoms less than 6 hours before hospital admission, associated with typical st-segment elevation on the 12-lead ecg * angiographic-detected culprit lesion with stenosis diameter \>70% and timi flow grade \<=1 exclusion criteria: * previous acute myocardial infarction * previous myocardial revascularization (angioplasty or coronary bypass) * previous heart valve replacement * previous heart transplant * clinical instability precluding the suitability of the study * cardiogenic shock or persistent hypotension (systolic blood pressure \<100 mmhg) * rescue angioplasty after thrombolytic therapy * evidence of coronary collaterals (rentrop grade\>0) in the risk area * advanced atrioventricular block * significant bradycardia * absence of sinus rhythm * inability to lay flat (due to severe cardiac heart failure/respiratory insufficiency) * history or clinical evidence of bronchospastic lung disease * pregnancy * known existence of a life-threatening disease with a life expectancy \<6 months * inability to give informed consent * any contraindication to undergo cardiac-mri, such as implanted metallic objects (cardiac pacemakers and/or implantable cardioverter defibrillator, implanted insulin pumps or any other type of electronic devices, cerebral clips, aneurysm clips) or any other contraindication to cardiac-mri (such as claustrophobia)

Keywords: acute myocardial infarction primary percutaneous coronary intervention postconditioning