Acute Myocardial Infarct Clinical Trial
Official title:
Intracoronary Injection of Epo During Reperfusion in Patients Hospitalized for First Acute Myocardial Infarct STEMI
Primary endpoint: Is intracoronary injection of a single dose of darbepoetin alpha, during
reperfusion in patients hospitalized for ST segment elevation myocardial infarction (STEMI),
able to reduce infarct size ?
In in vivo studies, many experiments evidenced infarct size reduction, due to anti-apoptotic
compounds, when given during reperfusion, after cardiac ischemia. In humans,
post-conditioning offers such a protection, as the investigators have previously showed
(Staat P et al. Post-conditioning the human heart. Circulation. 2005 112(14):2143-8).
Infarct size reduction could lead to a reduced rate of complications (heart failure,
rhythmic complications) and finally, morbidity and even mortality. This protection depends
on anti-apoptotic properties (Zhao ZQ et al. Inhibition of myocardial injury by ischemic
postconditioning during reperfusion: comparison with ischemic preconditioning. Am J
Physiology Heart Circ Physiology 2003 Aug; 285(2):H579-88). Many drugs have been proposed to
be able to mimic this phenomenon. Among them, many are efficient but toxic in vivo or
difficult to manage (insulin, morphin). One of the most promising agent could then be
erythropoietin (EPO) (Opie LH et al. Postconditioning for protection of the infarcting
heart. Lancet. 2006; 367(9509):456-8). In order to target ischemia-reperfusion injuries, EPO
impact is better and better demonstrated (e.g.: Mudalagiri NR. Erythropoietin protects the
human myocardium against hypoxia and reoxygenation injury via phosphatidylinositol-3 kinase
and ERK1-2 activation. Br J Pharmacol. 2007 Oct 22). The purpose of the study is to test
this hypothesis in humans, on the onset of the reperfusion, after myocardial ischemia (acute
myocardial infarct). EPO could contribute to protect myocardium against ischemia-reperfusion
injury. This impact could rely on anti-apoptotic properties.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | October 2011 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - ACS with persistent ST elevation - First episode - Symptoms onset < 12 hours - Eligible for angioplasty - Culprit coronary artery occluded (TIMI flow 0-1) at admission, and then adequately reperfused (TIMI flow 2-3) prior to EPO injection Exclusion Criteria: - Cardiogenic shock - Cardiac arrest - Currently receiving EPO - Pregnancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Montpellier University Hospital | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Magnetic resonance imaging (MRI) determination of infarct size | 12 weeks | No | |
| Secondary | Cardiac enzymes | 12 weeks | No | |
| Secondary | Echocardiography | 12 weeks | No |