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Morphine In Acute Myocardial Infarction (MIAMI)

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ClinicalTrials.gov Identifier: NCT01186445
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
French Cardiology Society

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).

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: morphine chlorhydrate Drug: saline solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction
Study Start Date : January 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Infarct size evaluated by delayed enhancement-magnetic resonance imaging [ Time Frame: between day 3 and day 5 after acute myocardial infarction (AMI) ]

Secondary Outcome Measures :
  1. Infarct size/area at risk ratio evaluated by MRI [ Time Frame: between day 3 and day 5 after AMI ]
  2. release of creatine kinase (CK) and troponin I (TnI) during reperfusion [ Time Frame: during the first 72 hours after reperfusion ]
    The Area Under the Curve of CK and TnI during reperfusion

  3. the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion [ Time Frame: at day 0 ]
  4. ST segment resolution after reperfusion [ Time Frame: during the first 24 hours after reperfusion ]
  5. Left Ventricular Ejection Fraction measured by echocardiography [ Time Frame: at day 1 and day 6 ]
  6. Infarct size measurement by delayed enhancement-magnetic resonance imaging [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186445


Locations
France
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
Investigators
Principal Investigator: Philippe Lecorvoisier, MD Henri Mondor Hospital

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01186445     History of Changes
Other Study ID Numbers: MIAMI-2008-09
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pharmaceutical Solutions
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents