Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

Study Overview
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Brief Summary
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Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin concentration after myocardial infarction/reperfusion and also beneficial for the patients undergoing percutaneous coronary intervention (PCI).

Detailed Description
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Ischemic/reperfusion injury in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) is associated with increased inflammatory cytokines that including TNF-alpha that can exert deleterious effects and therefore contribute to cardiac dysfunction and cardiomyocytes apoptosis. Several studies on rodents have reported administration of sTNFR-Fc, a scavenger of the pro-inflammatory cytokine TNF-alpha at the time of reperfusion would protect against ischemic/reperfusion injury. Also reports had shown that serum TNF-alpha concentration is negatively correlated with a cardioprotective cytokine adiponectin. Adiponectin (Ad) is an abundant protein hormone regulatory of numerous metabolic processes. The major intracellular pathway activated by Ad includes phosphorylation of AMP-activated protein kinase, which is responsible for many of Ad's metabolic regulatory, anti-inflammatory, vascular protective, and anti-ischemic properties. The aim of the present study was to verify whether the administration of Etanercept, an FDA approved rheumatoid arthritis treating sTNFR-Fc, at the reperfusion time would protect against ischemic/reperfusion injury on patient, and effect serum adiponectin level.

Official Title
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The Safety and Efficacy of Etanercept in Treating Patient With Acute ST Segment Elevated Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Etanercept
* Drug: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with acute ST segment elevated myocardial infarction in 12h Exclusion Criteria: Cardiogenic shock old myocardial infarction other causes of cardiac insufficiency tumor Coronary anatomy unsuitable for PCI or Need of emergency coronary artery by-pass grafting Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etanercept<br> | Drug: Etanercept<br>* Etanercept 25mg in 1ml(subcutaneous injection)at 2h and 72h after PCI<br>* Other names: Enbrel;|
| Placebo Comparator: saline<br> | Drug: saline<br>* saline 1ml(subcutaneous injection) at 2h and 72h after PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of major cardiovascular events, non-elective coronary revascularization procedures and hospitalization for unstable angina Cardiovascular death Non-fatal myocardial infarction Non-fatal stroke of all classifications |  | 30 days | 
| Elevation of ALT, AST and CK |  | 30 days | 
| serum adiponectin concentration, activity and isoforms |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etanercept, acute ST segment elevated myocardial infarction, percutaneous coronary intervention, myocardial reperfusion injury