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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The purpose of this study is to determine whether intracoronary injection of morphine chlorhydrate is effective to limit ischemia-reperfusion lesion during percutaneous coronary angioplasty in patients with acute myocardial infarction (AMI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine chlorhydrate | Experimental | Intracoronary injection of morphine chlorhydrate during reperfusion |
|
| Saline solution | Placebo Comparator | Intracoronary injection of saline solution during reperfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| morphine chlorhydrate | Drug | 1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size evaluated by delayed enhancement-magnetic resonance imaging | between day 3 and day 5 after acute myocardial infarction (AMI) |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size/area at risk ratio evaluated by MRI | between day 3 and day 5 after AMI | |
| release of creatine kinase (CK) and troponin I (TnI) during reperfusion | The Area Under the Curve of CK and TnI during reperfusion |
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Inclusion Criteria:
Acute Myocardial Infarction less than 6 hours defined by
prolonged chest pain (>15 min)
in association with
Culprit lesion eligible for percutaneous coronary intervention (PCI)
TIMI flow 0 before PCI
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Lecorvoisier, MD | Henri Mondor University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henri Mondor Hospital | Créteil | 94010 | France | |||
| Hopital Marie Lannelongue |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30340532 | Derived | Le Corvoisier P, Gallet R, Lesault PF, Audureau E, Paul M, Ternacle J, Ghostine S, Champagne S, Arrouasse R, Bitari D, Mouillet G, Dubois-Rande JL, Berdeaux A, Ghaleh B, Deux JF, Teiger E. Intra-coronary morphine versus placebo in the treatment of acute ST-segment elevation myocardial infarction: the MIAMI randomized controlled trial. BMC Cardiovasc Disord. 2018 Oct 19;18(1):193. doi: 10.1186/s12872-018-0936-8. |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| saline solution | Drug | 3 ml of saline solution , intracoronary injection during reperfusion |
|
| during the first 72 hours after reperfusion |
| the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion | at day 0 |
| ST segment resolution after reperfusion | during the first 24 hours after reperfusion |
| Left Ventricular Ejection Fraction measured by echocardiography | at day 1 and day 6 |
| Infarct size measurement by delayed enhancement-magnetic resonance imaging | 1 year |
| Le Plessis-Robinson |
| 92350 |
| France |