Morphine In Acute Myocardial Infarction (MIAMI)

February 3, 2017 updated by: French Cardiology Society

Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Henri Mondor Hospital
      • Plessis Robinson, France, 92350
        • Hopital Marie Lannelongue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infarct size evaluated by delayed enhancement-magnetic resonance imaging
Time Frame: between day 3 and day 5 after acute myocardial infarction (AMI)
between day 3 and day 5 after acute myocardial infarction (AMI)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size/area at risk ratio evaluated by MRI
Time Frame: between day 3 and day 5 after AMI
between day 3 and day 5 after AMI
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
during the first 72 hours after reperfusion
the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion
Time Frame: at day 0
at day 0
ST segment resolution after reperfusion
Time Frame: during the first 24 hours after reperfusion
during the first 24 hours after reperfusion
Left Ventricular Ejection Fraction measured by echocardiography
Time Frame: at day 1 and day 6
at day 1 and day 6
Infarct size measurement by delayed enhancement-magnetic resonance imaging
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Philippe Lecorvoisier, MD, Henri Mondor University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIAMI-2008-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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