Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

NCT ID: NCT01372930

Last Updated: 2011-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

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

saline

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

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

Interventions

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Etanercept

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

Intervention Type DRUG

saline

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

Intervention Type DRUG

Other Intervention Names

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Enbrel

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Cardiology of Xijing Hospital; Fourth Military Medical University

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ling Tao, M.D Ph.D

Role: CONTACT

+86-15002955798

Facility Contacts

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Ling Tao, M.D Ph.D

Role: primary

+86-15002955798

Other Identifiers

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xjyy110504

Identifier Type: -

Identifier Source: org_study_id

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