Morphine In Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— MIAMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186445
• Other study ID #: MIAMI-2008-09
• Status: Completed
• Phase: Phase 3
• First received: August 20, 2010
• Last updated: February 3, 2017
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• morphine chlorhydrate
1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion
• saline solution
3 ml of saline solution , intracoronary injection during reperfusion

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil
France	Hopital Marie Lannelongue	Plessis Robinson

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size evaluated by delayed enhancement-magnetic resonance imaging		between day 3 and day 5 after acute myocardial infarction (AMI)
Secondary	Infarct size/area at risk ratio evaluated by MRI		between day 3 and day 5 after AMI
Secondary	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
Secondary	the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion		at day 0
Secondary	ST segment resolution after reperfusion		during the first 24 hours after reperfusion
Secondary	Left Ventricular Ejection Fraction measured by echocardiography		at day 1 and day 6
Secondary	Infarct size measurement by delayed enhancement-magnetic resonance imaging		1 year