Morphine In Acute Myocardial Infarction

Study Overview
=================
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).

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

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: morphine chlorhydrate
* Drug: saline solution


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morphine chlorhydrate<br>Intracoronary injection of morphine chlorhydrate during reperfusion | Drug: morphine chlorhydrate<br>* 1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion<br>* Other names: Morphine Chlorhydrate Lavoisier;|
| Placebo Comparator: Saline solution<br>Intracoronary injection of saline solution during reperfusion | Drug: saline solution<br>* 3 ml of saline solution , intracoronary injection during reperfusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size evaluated by delayed enhancement-magnetic resonance imaging |  | 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 |  | between day 3 and day 5 after AMI | 
| release of creatine kinase (CK) and troponin I (TnI) during 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 |  | at day 0 | 
| ST segment resolution after reperfusion |  | during the first 24 hours after reperfusion | 
| Left Ventricular Ejection Fraction measured by echocardiography |  | at day 1 and day 6 | 
| Infarct size measurement by delayed enhancement-magnetic resonance imaging |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myocardial Infarction, Cardioprotective effect, Pharmacological postconditioning, Morphine Chlorhydrate, Cardiac MRI