Acute Myocardial Infarction
Conditions
Keywords
Acute Myocardial Infarction, Cardioprotective effect, Pharmacological postconditioning, Morphine Chlorhydrate, Cardiac MRI
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).
Interventions
1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion
DRUGsaline solution
3 ml of saline solution , intracoronary injection during reperfusion
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
French Cardiology Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infarct size evaluated by delayed enhancement-magnetic resonance imaging | between day 3 and day 5 after acute myocardial infarction (AMI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| release of creatine kinase (CK) and troponin I (TnI) during reperfusion | during the first 72 hours after reperfusion | The Area Under the Curve of CK and TnI during reperfusion |
| the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion | at day 0 | — |
| Infarct size/area at risk ratio evaluated by MRI | between day 3 and day 5 after AMI | — |
| Left Ventricular Ejection Fraction measured by echocardiography | at day 1 and day 6 | — |
| Infarct size measurement by delayed enhancement-magnetic resonance imaging | 1 year | — |
| ST segment resolution after reperfusion | during the first 24 hours after reperfusion | — |
Countries
France
Outcome results
None listed