Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
94 participants
INTERVENTIONAL
2011-01-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Morphine chlorhydrate
Intracoronary injection of morphine chlorhydrate during reperfusion
morphine chlorhydrate
1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion
Saline solution
Intracoronary injection of saline solution during reperfusion
saline solution
3 ml of saline solution , intracoronary injection during reperfusion
Interventions
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morphine chlorhydrate
1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion
saline solution
3 ml of saline solution , intracoronary injection during reperfusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. prolonged chest pain (\>15 min)
2. in association with
* ST elevation 1mm or more in two contiguous leads
* or occurence of Q wave in three contiguous leads
* or occurence of left bundle branch block
2. Culprit lesion eligible for percutaneous coronary intervention (PCI)
3. TIMI flow 0 before PCI
Exclusion Criteria
2. Allergy to morphine
3. Active epilepsy
4. Brain injury or intracranial hypertension
5. Previous AMI, coronary artery bypass graft (CABG)
6. Cardiac arrest
7. Cardiogenic shock, significant mitral regurgitation or intraventricular communication at inclusion
8. Mechanical ventilation at inclusion
9. Significant ventricular arrhythmia or atrioventricular block type II or III at inclusion
10. Decompensated chronic obstructive pulmonary disease at inclusion
11. chronic hepatocellular failure
12. MRI contraindications
13. Gadolinium chelates injection contraindications
14. Current treatment with morphine chlorhydrate, buprenorphine, nalbuphine, pentazocine
18 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
French Cardiology Society
OTHER
Responsible Party
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Principal Investigators
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Philippe Lecorvoisier, MD
Role: PRINCIPAL_INVESTIGATOR
Henri Mondor University Hospital
Locations
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Henri Mondor Hospital
Créteil, , France
Hopital Marie Lannelongue
Le Plessis-Robinson, , France
Countries
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References
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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.
Other Identifiers
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MIAMI-2008-09
Identifier Type: -
Identifier Source: org_study_id
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