Clinical trial NCT01186445: Morphine In Acute Myocardial Infarction
Official title: Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Cardioprotective effect
Pharmacological postconditioning
Morphine Chlorhydrate
Cardiac MRI
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2010-08-23
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Acute Myocardial Infarction less than 6 hours defined by

   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:

1. Fibrinolysis
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

Primary outcomes:
measure: Infarct size evaluated by delayed enhancement-magnetic resonance imaging
timeFrame: between day 3 and day 5 after acute myocardial infarction (AMI)
Secondary outcomes:
measure: Infarct size/area at risk ratio evaluated by MRI
timeFrame: between day 3 and day 5 after AMI
measure: release of creatine kinase (CK) and troponin I (TnI) during reperfusion
timeFrame: during the first 72 hours after reperfusion
measure: the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion
timeFrame: at day 0
measure: ST segment resolution after reperfusion
timeFrame: during the first 24 hours after reperfusion
measure: Left Ventricular Ejection Fraction measured by echocardiography
timeFrame: at day 1 and day 6
measure: Infarct size measurement by delayed enhancement-magnetic resonance imaging
timeFrame: 1 year
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
city: Plessis Robinson
country: France
facility: Hopital Marie Lannelongue
Study officials:
affiliation: Henri Mondor University Hospital
name: Philippe Lecorvoisier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.