Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Etanercept
saline
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Etanercept, acute ST segment elevated myocardial infarction, percutaneous coronary intervention, myocardial reperfusion injury
Eligibility 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
Sites / Locations
- Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Etanercept
saline
Arm Description
Outcomes
Primary Outcome Measures
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke
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
Elevation of ALT, AST and CK
serum adiponectin concentration, activity and isoforms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01372930
Brief Title
Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction
Official Title
The Safety and Efficacy of Etanercept in Treating Patient With Acute ST Segment Elevated Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Etanercept, acute ST segment elevated myocardial infarction, percutaneous coronary intervention, myocardial reperfusion injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Etanercept
Arm Type
Experimental
Arm Title
saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
Etanercept 25mg in 1ml(subcutaneous injection)at 2h and 72h after PCI
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
saline 1ml(subcutaneous injection) at 2h and 72h after PCI
Primary Outcome Measure Information:
Title
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke
Time Frame
30 days
Secondary Outcome Measure Information:
Title
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
Title
Elevation of ALT, AST and CK
Time Frame
30 days
Title
serum adiponectin concentration, activity and isoforms
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Tao, M.D Ph.D
Phone
+86-15002955798
Email
lingtao2006@gmail.com
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Tao, M.D Ph.D
Phone
+86-15002955798
Email
lingtao2006@gmail.com
First Name & Middle Initial & Last Name & Degree
Ling Tao, M.D Ph.D
12. IPD Sharing Statement
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Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction
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