Postconditioning in Primary PCI and Direct Stenting

Clinical and MRI Evaluation of 2 Vs 4 Cycles of Postconditioning During Primary PCI With Direct Stenting

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.

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.

Staat P, Rioufol G, Piot C, Cottin Y, Cung TT, L'Huillier I, Aupetit JF, Bonnefoy E, Finet G, Andre-Fouet X, Ovize M. Postconditioning the human heart. Circulation. 2005 Oct 4;112(14):2143-8. doi: 10.1161/CIRCULATIONAHA.105.558122. Epub 2005 Sep 26.

Zhao ZQ, Corvera JS, Halkos ME, Kerendi F, Wang NP, Guyton RA, Vinten-Johansen J. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiol Heart Circ Physiol. 2003 Aug;285(2):H579-88. doi: 10.1152/ajpheart.01064.2002. Erratum In: Am J Physiol Heart Circ Physiol. 2004 Jan;286(1):H477.