Morphine In Acute Myocardial Infarction

Phase 3

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: morphine chlorhydrate; Drug: saline solution

• Registration Number: NCT01186445
• Lead Sponsor: French Cardiology Society

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Study Start: 2011-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine chlorhydrate	morphine chlorhydrate	Intracoronary injection of morphine chlorhydrate during reperfusion
Saline solution	saline solution	Intracoronary injection of saline solution during reperfusion

Primary Outcome Measures

Name	Time	Method
Infarct size evaluated by delayed enhancement-magnetic resonance imaging	between day 3 and day 5 after acute myocardial infarction (AMI)

Secondary Outcome Measures

Name	Time	Method
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
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/area at risk ratio evaluated by MRI	between day 3 and day 5 after AMI
Infarct size measurement by delayed enhancement-magnetic resonance imaging	1 year

Trial Locations

Locations (2)

Hopital Marie Lannelongue; 🇫🇷 Plessis Robinson, France

Henri Mondor Hospital; 🇫🇷 Creteil, France