Morphine In Acute Myocardial Infarction (MIAMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by French Cardiology Society
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01186445
First received: August 20, 2010
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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 2015
Estimated Primary Completion Date: March 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186445

Contacts
Contact: Philippe Lecorvoisier, MD +33149813789 philippe.lecorvoisier@hmn.aphp.fr
Contact: Anissa Bouzamondo, MD +33143221379 anissa.bouzamondo@cardio-sfc.org

Locations
France
Hopital Privé d'Antony Withdrawn
Antony, France, 92160
Antoine Beclere Hospital Withdrawn
Clamart, France, 92141
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Philippe Lecorvoisier, MD    +33149813789    philippe.lecorvoisier@hmn.aphp.fr   
Sub-Investigator: Pierre-François Lesault, MD         
Sub-Investigator: Emmanuel Teiger, MD, PHD         
Sub-Investigator: Dubois-Randé Jean-Luc, MD, PHD         
Sub-Investigator: Stéphane Champagne, MD         
Sub-Investigator: Abdel Belarbi, MD         
Sub-Investigator: Barnabas Gellen, MD, PHD         
Sub-Investigator: Gauthier Mouillet, MD         
Principal Investigator: Philippe Lecorvoisier, MD         
Hopital Marie Lannelongue Recruiting
Plessis Robinson, France, 92350
Contact: Christophe Caussin, PR    +33140948547    c.caussin@ccml.fr   
Sub-Investigator: Christophe Caussin, MD         
Sub-Investigator: Nicolas Amabile, MD         
Sub-Investigator: Said Ghostine, MD         
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
  More Information

No publications provided

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01186445     History of Changes
Other Study ID Numbers: MIAMI-2008-09
Study First Received: August 20, 2010
Last Updated: October 8, 2014
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:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Morphine
Pharmaceutical Solutions
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014