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Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01372930
Enrollment
200
Registered
2011-06-14
Start date
2010-04-30
Completion date
Unknown
Last updated
2011-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Etanercept, acute ST segment elevated myocardial infarction, percutaneous coronary intervention, myocardial reperfusion injury

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.

Interventions

DRUGEtanercept

Etanercept 25mg in 1ml(subcutaneous injection)at 2h and 72h after PCI

DRUGsaline

saline 1ml(subcutaneous injection) at 2h and 72h after PCI

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke30 days

Secondary

MeasureTime 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 classifications30 days
Elevation of ALT, AST and CK30 days
serum adiponectin concentration, activity and isoforms30 days

Countries

China

Contacts

Primary ContactLing Tao, M.D Ph.D
lingtao2006@gmail.com+86-15002955798

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026