Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

Phase 4

• Conditions: Myocardial Infarction
• Interventions: Drug: saline; Drug: Etanercept

• Registration Number: NCT01372930
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-04
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-11
• Last Update Submitted: 2011-06-11
• Study First Posted: 2011-06-14
• Last Update Posted: 2011-06-14
• Primary Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	saline	-
Etanercept	Etanercept	-

Primary Outcome Measures

Name	Time	Method
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke	30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China