Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

This study is currently recruiting participants.
Verified March 2010 by Xijing Hospital
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01372930
First received: June 10, 2011
Last updated: June 11, 2011
Last verified: March 2010
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: Etanercept
Drug: saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Etanercept in Treating Patient With Acute ST Segment Elevated Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Elevation of ALT, AST and CK [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • serum adiponectin concentration, activity and isoforms [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372930

Contacts
Contact: Ling Tao, M.D Ph.D +86-15002955798 lingtao2006@gmail.com

Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ling Tao, M.D Ph.D    +86-15002955798    lingtao2006@gmail.com   
Principal Investigator: Ling Tao, M.D Ph.D         
Sponsors and Collaborators
Xijing Hospital
  More Information

No publications provided

Responsible Party: Ling Tao, Department of Cardiology of Xijing Hospital; Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01372930     History of Changes
Other Study ID Numbers: xjyy110504
Study First Received: June 10, 2011
Last Updated: June 11, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014