postconditioning in primary pci and direct stenting

Conditions: Myocardial Infarction

Summary: to determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary pci and direct stenting in acute mi, and to compared to primary pci and direct stenting without the postconditioning.

sample size: 45 subjects site locations: sheba medical center patients: patients presenting with an acute mi with onset of symptoms  6h, and planned to undergo primary pci will be included. the target lesion should be located in the proximal or middle segment of a main native coronary artery, and should be suitable for percutaneous intervention. primary objective: to determine the safety and efficacy of 2 vs 4 cycles of postconditioning method during primary pci and direct stenting in acute mi, and to compared to primary pci and direct stenting without the postconditioning. primary endpoint: * st segment resolution. * segmental wall motion score, resolution of edema and wall thickness by echocardiography. * infarct size estimation by cardiac enzymes and cardiac mri. secondary endpoints: * composite endpoint of major adverse cardiac events (mace) at 30 and 90 days methods: * ecg at baseline, immediately after procedure, 90 and 180 minutes after the procedure and 6-24 hours after intervention. * core laboratory angiography measurements of timi flow, corrected timi frame count, myocardial blush score and left ventricular angiography. * myocardial enzymes measurements: every 4 hours in the first 24 hours and every 6 hours in the following 48 hours. * left ventricular ejection fraction and wall motion score determined by echocardiography. * cardiac mri estimation of infarct size. • clinical follow-up at 30 and 90 days post procedure. follow-up: * follow up at 30 days: clinical. * clinical follow up \& cardiac mri at 90 days.

Eligibility criteria:
inclusion criteria: * patient is \> 21 years of age and provides informed consent. * evidence of ami as indicated by signs and symptoms. diagnosis of st-segment elevation ami will be based on chest pain for \>30 minutes and st-segment elevation of \>1mv in 2 limb lead or \>2mv in 2 anterior leads contiguous leads on the 12-lead ecg. * eligible to undergo primary pci. * symptom duration is \< 6 hours prior to primary pci. * angiographic: the target lesion in the infarct related artery (ira) should be occluded (timi). * angiographic: the target lesion in the proximal or middle segment of a native major coronary artery (lad, rca or dominant cx). * angiographic: the target lesion should be suitable for ptca or stenting. * angiographic: the ira occlusion will be successfully opened by stenting with timi 2-3 exclusion criteria: * unwillingness to participate. * prior acute mi * cardiac arrest or killip score iii-iv * women with known pregnancy. * active significant bleeding. * known allergy for aspirin, ticlopidine and clopidogrel, or heparin. * chronic renal failure with creatinine \> 2 mg/dl * other medical illness associated with limited life expectancy or that may cause the patient to be non-compliant with the protocol. * current participation in other trials using investigational drugs or devices. * contraindications to mri including: arrythmias, cardiac pacer, brain aneurysm clips, cochlear implants, nerve stimulator.

Keywords: myocardial infarction primary pci postconditioning mri