Morphine In Acute Myocardial Infarction (MIAMI)

This study is ongoing, but not recruiting participants.
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
French Cardiology Society Identifier:
First received: August 20, 2010
Last updated: February 2, 2016
Last verified: February 2016
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).

Condition Intervention Phase
Acute Myocardial Infarction
Drug: morphine chlorhydrate
Drug: saline solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Infarct size evaluated by delayed enhancement-magnetic resonance imaging [ Time Frame: between day 3 and day 5 after acute myocardial infarction (AMI) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infarct size/area at risk ratio evaluated by MRI [ Time Frame: between day 3 and day 5 after AMI ] [ Designated as safety issue: No ]
  • release of creatine kinase (CK) and troponin I (TnI) during reperfusion [ Time Frame: during the first 72 hours after reperfusion ] [ Designated as safety issue: No ]
    The Area Under the Curve of CK and TnI during reperfusion

  • the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion [ Time Frame: at day 0 ] [ Designated as safety issue: No ]
  • ST segment resolution after reperfusion [ Time Frame: during the first 24 hours after reperfusion ] [ Designated as safety issue: No ]
  • Left Ventricular Ejection Fraction measured by echocardiography [ Time Frame: at day 1 and day 6 ] [ Designated as safety issue: No ]
  • Infarct size measurement by delayed enhancement-magnetic resonance imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 94
Study Start Date: January 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine chlorhydrate
Intracoronary injection of morphine chlorhydrate during reperfusion
Drug: morphine chlorhydrate
1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion
Other Name: Morphine Chlorhydrate Lavoisier
Placebo Comparator: Saline solution
Intracoronary injection of saline solution during reperfusion
Drug: saline solution
3 ml of saline solution , intracoronary injection during reperfusion


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01186445

Henri Mondor Hospital
Creteil, France, 94010
Hopital Marie Lannelongue
Plessis Robinson, France, 92350
Sponsors and Collaborators
French Cardiology Society
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Philippe Lecorvoisier, MD Henri Mondor Hospital
  More Information

Responsible Party: French Cardiology Society Identifier: NCT01186445     History of Changes
Other Study ID Numbers: MIAMI-2008-09 
Study First Received: August 20, 2010
Last Updated: February 2, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French Cardiology Society:
Acute Myocardial Infarction
Cardioprotective effect
Pharmacological postconditioning
Morphine Chlorhydrate
Cardiac MRI

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Pharmaceutical Solutions
Analgesics, Opioid
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 30, 2016