Postconditioning in Primary PCI and Direct Stenting

Sheba Medical Center45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myocardial Infarction

Interventions

PostconditioningPROCEDURE

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.