Effect of N-acetylcystein in Myocardial Infarction

Study Overview
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Brief Summary
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We designed this study to evaluate the effect of N-acetylcystein on biomarkers of platelet activation , cardiac necrosis and coronary reperfusion in patients undergoing percutaneous coronary intervention.

Detailed Description
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Percutaneous coronary intervention(PCI) is one of the standard therapies for acute coronary syndrome. Despite major advances in PCI procedure, impaired myocardial perfusion frequently occurred after primary PCI and resulted in a larger infarct size and increased morbidity and mortality.Reperfusion injury process can be resulted in additional death of cardiomyocytes and it is suggested that oxidative stress is a contributing factor to induce reperfusion injury.During PCI,trauma occurs to the arterial endothelium, causes the activation and aggregation of platelets. It is estimated that approximately 25% of patients undergoing PCI have significant postprocedural creatinine kinase (CK)/creatinine kinase myocardial band (CK-MB) elevations and approximately 50% of patients have significant post-procedural troponin elevations. The most common complication of PCI is a cell damage to cardiomyocyte that can be diagnosed by postprocedure elevation of cardiac markers. N-acetylcystein have several positive effect on platelet and vascular function and infarct size. This study is a randomized clinical trial (RCT) evaluating the effect of N-acetylcystein on biomarkers of platelet activation and coronary reperfusion in patients undergoing percutaneous coronary intervention. Double blind randomized clinical trial on 100 patients in 2 groups (intervention & control) is conducted. Patients with confirmed ST-elevation myocardial infarction included in this study. Patients were excluded if they had: emergency for cardiac bypass; cardiogenic shock and rescue percutaneous coronary intervention. Patients in Intervention group were administered 100 mg/kg Iv bolus N-acetylcystein and then 480mg intracoronary and 10mg/kg/h over 12 hours after percutaneous coronary intervention and patients in control group received standard regimens. Primary outcome was platelet activation biomarkers assessment before and 24 hours after percutaneous coronary intervention and secondary outcome was effect of N-acetylcystein on CK-MB and high sensitive Troponin T, 6 and 12 hours after percutaneous coronary intervention.Patients were assessed for coronary blood flow after percutaneous coronary intervention with the use of TIMI flow and myocardial blush grade. Major adverse cardiac events (MACE) will be evaluated as a secondary endpoint after 30 days.

Official Title
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Evaluation of N-acetylcystein on Biomarkers of Platelet Activation , Cardiac Necrosis and Coronary Reperfusion in Patients Undergoing Percutaneous Coronary Intervention

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: N-acetylcystein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Myocardial infarction patients who were candidate of primary PCI Exclusion Criteria: Rescue PCI Emergency for cardiac bypass Cardiogenic shock Life expectancy less than 6 months Age less than 18 years old Uncontrolled hypertension Thrombocytopenia Malformation or aneurysm Sever chronic kidney disease Sever liver failure Major surgery within 3 months Unsatisfactory to enter the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>control This group is without N-acetylcystein : just receives standard treatment | |
| Active Comparator: N-acetylcystein<br>receive N-acetylcystein in addition to standard treatment Ampoule 200 mg/ml | Drug: N-acetylcystein<br>* Active Comparator: N-acetylcystein receive N-acetylcystein in addition to standard treatment<br>* Other names: EXI-NACE,NAC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of platelet activation (P selectin- CD40L-IL[Interleukin] 10- TGF[Transforming Growth Factor]-beta) |  | Change from the baseline after 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Necrosis Biomarkers (CKMB, Troponin T) | difference between study and control group in 6 and 12 hrs after percutaneous coronary intervention | Change from the baseline after 12 hours | 
| score of coronary blood flow(TIMI flow and MBG) |  | Change from the baseline after percutaneous coronary intervention | 
| MACE (Major Adverse Cardiac Effect) | Defined as Need for Target Revascularization, Myocardial Infarction and Death | 30 days |