Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01372930
Recruitment Status : Unknown
Verified March 2010 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : June 14, 2011
Last Update Posted : June 14, 2011
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Etanercept Drug: saline Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Etanercept in Treating Patient With Acute ST Segment Elevated Myocardial Infarction
Study Start Date : April 2010
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: Etanercept Drug: Etanercept
Etanercept 25mg in 1ml(subcutaneous injection)at 2h and 72h after PCI
Other Name: Enbrel

Placebo Comparator: saline Drug: saline
saline 1ml(subcutaneous injection) at 2h and 72h after PCI

Primary Outcome Measures :
  1. Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 30 days ]
  2. Elevation of ALT, AST and CK [ Time Frame: 30 days ]
  3. serum adiponectin concentration, activity and isoforms [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01372930

Contact: Ling Tao, M.D Ph.D +86-15002955798

China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ling Tao, M.D Ph.D    +86-15002955798   
Principal Investigator: Ling Tao, M.D Ph.D         
Sponsors and Collaborators
Xijing Hospital

Responsible Party: Ling Tao, Department of Cardiology of Xijing Hospital; Fourth Military Medical University Identifier: NCT01372930     History of Changes
Other Study ID Numbers: xjyy110504
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: March 2010

Keywords provided by Xijing Hospital:
acute ST segment elevated myocardial infarction
percutaneous coronary intervention
myocardial reperfusion injury

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors