Postconditioning in Primary PCI and Direct Stenting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Postconditioning


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Postconditioning|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of Major Adverse Cardiac Events (MACE) at 30 and 90 days |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Primary PCI, Postconditioning, MRI