Back to resultsMorphine In Acute Myocardial Infarction (MIAMI)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
morphine chlorhydrate
saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction, Cardioprotective effect, Pharmacological postconditioning, Morphine Chlorhydrate, Cardiac MRI
Eligibility Criteria
Inclusion Criteria:
Acute Myocardial Infarction less than 6 hours defined by
- prolonged chest pain (>15 min)
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
- Culprit lesion eligible for percutaneous coronary intervention (PCI)
- TIMI flow 0 before PCI
Exclusion Criteria:
- Fibrinolysis
- Allergy to morphine
- Active epilepsy
- Brain injury or intracranial hypertension
- Previous AMI, coronary artery bypass graft (CABG)
- Cardiac arrest
- Cardiogenic shock, significant mitral regurgitation or intraventricular communication at inclusion
- Mechanical ventilation at inclusion
- Significant ventricular arrhythmia or atrioventricular block type II or III at inclusion
- Decompensated chronic obstructive pulmonary disease at inclusion
- chronic hepatocellular failure
- MRI contraindications
- Gadolinium chelates injection contraindications
- Current treatment with morphine chlorhydrate, buprenorphine, nalbuphine, pentazocine
Sites / Locations
- Henri Mondor Hospital
- Hopital Marie Lannelongue
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Morphine chlorhydrate
Saline solution
Arm Description
Intracoronary injection of morphine chlorhydrate during reperfusion
Intracoronary injection of saline solution during reperfusion
Outcomes
Primary Outcome Measures
Infarct size evaluated by delayed enhancement-magnetic resonance imaging
Secondary Outcome Measures
Infarct size/area at risk ratio evaluated by MRI
release of creatine kinase (CK) and troponin I (TnI) during reperfusion
The Area Under the Curve of CK and TnI during reperfusion
the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion
ST segment resolution after reperfusion
Left Ventricular Ejection Fraction measured by echocardiography
Infarct size measurement by delayed enhancement-magnetic resonance imaging
Full Information
NCT ID
NCT01186445
First Posted
August 20, 2010
Last Updated
February 3, 2017
Sponsor
French Cardiology Society
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01186445
Brief Title
Morphine In Acute Myocardial Infarction
Acronym
MIAMI
Official Title
Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute Myocardial Infarction, Cardioprotective effect, Pharmacological postconditioning, Morphine Chlorhydrate, Cardiac MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morphine chlorhydrate
Arm Type
Experimental
Arm Description
Intracoronary injection of morphine chlorhydrate during reperfusion
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
Intracoronary injection of saline solution during reperfusion
Intervention Type
Drug
Intervention Name(s)
morphine chlorhydrate
Other Intervention Name(s)
Morphine Chlorhydrate Lavoisier
Intervention Description
1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion
Intervention Type
Drug
Intervention Name(s)
saline solution
Intervention Description
3 ml of saline solution , intracoronary injection during reperfusion
Primary Outcome Measure Information:
Title
Infarct size evaluated by delayed enhancement-magnetic resonance imaging
Time Frame
between day 3 and day 5 after acute myocardial infarction (AMI)
Secondary Outcome Measure Information:
Title
Infarct size/area at risk ratio evaluated by MRI
Time Frame
between day 3 and day 5 after AMI
Title
release of creatine kinase (CK) and troponin I (TnI) during reperfusion
Description
The Area Under the Curve of CK and TnI during reperfusion
Time Frame
during the first 72 hours after reperfusion
Title
the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion
Time Frame
at day 0
Title
ST segment resolution after reperfusion
Time Frame
during the first 24 hours after reperfusion
Title
Left Ventricular Ejection Fraction measured by echocardiography
Time Frame
at day 1 and day 6
Title
Infarct size measurement by delayed enhancement-magnetic resonance imaging
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute Myocardial Infarction less than 6 hours defined by
prolonged chest pain (>15 min)
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
Culprit lesion eligible for percutaneous coronary intervention (PCI)
TIMI flow 0 before PCI
Exclusion Criteria:
Fibrinolysis
Allergy to morphine
Active epilepsy
Brain injury or intracranial hypertension
Previous AMI, coronary artery bypass graft (CABG)
Cardiac arrest
Cardiogenic shock, significant mitral regurgitation or intraventricular communication at inclusion
Mechanical ventilation at inclusion
Significant ventricular arrhythmia or atrioventricular block type II or III at inclusion
Decompensated chronic obstructive pulmonary disease at inclusion
chronic hepatocellular failure
MRI contraindications
Gadolinium chelates injection contraindications
Current treatment with morphine chlorhydrate, buprenorphine, nalbuphine, pentazocine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Lecorvoisier, MD
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Marie Lannelongue
City
Plessis Robinson
ZIP/Postal Code
92350
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30340532
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.
Results Reference
derived
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Morphine In Acute Myocardial Infarction
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