Intracoronary Injection of Epo After Myocardial Infarct "Intra-CO-EpoMI"
Primary Purpose
Acute Myocardial Infarct
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Darbepoetin alfa
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarct focused on measuring STEMI, AMI,, acute myocardial infarct, Epo, Erythropoietin, ischemia-reperfusion, apoptosis
Eligibility Criteria
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
Sites / Locations
- Montpellier University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
EPO
Placebo
Arm Description
single bolus of EPO, 150 µg
NaCl
Outcomes
Primary Outcome Measures
Magnetic resonance imaging (MRI) determination of infarct size
Secondary Outcome Measures
Cardiac enzymes
Echocardiography
Full Information
NCT ID
NCT01043991
First Posted
September 22, 2009
Last Updated
May 31, 2016
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01043991
Brief Title
Intracoronary Injection of Epo After Myocardial Infarct "Intra-CO-EpoMI"
Official Title
Intracoronary Injection of Epo During Reperfusion in Patients Hospitalized for First Acute Myocardial Infarct STEMI
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Multiple Centers.:
5 centers located in France:
Montpellier
Clermont-Ferrand
Lyon
Marseille
Nîmes
Study design: Open-label, placebo-controlled, single-blinded. Patient in treatment group will receive intracoronary single bolus of EPO (150 µg), as soon as significant reperfusion is obtained (as measured by TIMI flow 2 or 3). In control group, placebo will be used. Placebo must be presented exactly the same as the drug.
Length of Treatment: One shot during reperfusion procedure.
Follow-up Period: 72nd hour post-admission for plasma kinetics of cardiac enzymes 5th to 7th day after revascularization procedure for MRI measurements, and echocardiography3th month post-MI MRI, echocardiography3th month: phone contact.
Sample Size: 27 patients in each arm, 54 patients total.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarct
Keywords
STEMI, AMI,, acute myocardial infarct, Epo, Erythropoietin, ischemia-reperfusion, apoptosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPO
Arm Type
Experimental
Arm Description
single bolus of EPO, 150 µg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
NaCl
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Magnetic resonance imaging (MRI) determination of infarct size
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cardiac enzymes
Time Frame
12 weeks
Title
Echocardiography
Time Frame
12 weeks
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe PIOT, Pr
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23582675
Citation
Roubille F, Micheau A, Combes S, Thibaut S, Souteyrand G, Cayla G, Bonello L, Lesavre N, Sportouch-Dukhan C, Klein F, Berboucha S, Cade S, Cung TT, Raczka F, Macia JC, Gervasoni R, Cransac F, Leclercq F, Barrere-Lemaire S, Paganelli F, Mottref P, Vernhet Kovacsik H, Ovize M, Piot C. Intracoronary administration of darbepoetin-alpha at onset of reperfusion in acute myocardial infarction: results of the randomized Intra-Co-EpoMI trial. Arch Cardiovasc Dis. 2013 Mar;106(3):135-45. doi: 10.1016/j.acvd.2012.12.001. Epub 2013 Feb 1.
Results Reference
derived
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Intracoronary Injection of Epo After Myocardial Infarct "Intra-CO-EpoMI"
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