Etanercept Treating Patient With Acute ST Segment Elevated Myocardial Infarction
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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 |
- 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 ]
- 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 |
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| Contact: Ling Tao, M.D Ph.D | +86-15002955798 | lingtao2006@gmail.com |
| 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 | |
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 June 18, 2013