Morphine In Acute Myocardial Infarction (MIAMI)

French Cardiology Society

Status and phase: Completed; Phase 3

Conditions: Acute Myocardial Infarction

Treatments: Drug: saline solution; Drug: morphine chlorhydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01186445

MIAMI-2008-09

Details and patient eligibility

About

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).

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

94 participants in 2 patient groups, including a placebo group

Morphine chlorhydrate

Experimental group

Description:

Intracoronary injection of morphine chlorhydrate during reperfusion

Treatment:

Drug: morphine chlorhydrate

Saline solution

Placebo Comparator group

Description:

Intracoronary injection of saline solution during reperfusion

Treatment:

Drug: saline solution