Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Xijing Hospital.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014