Morphine In Acute Myocardial Infarction
Information source: French Cardiology Society
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction
Intervention: morphine chlorhydrate (Drug); saline solution (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: French Cardiology Society Official(s) and/or principal investigator(s): Philippe Lecorvoisier, MD, Principal Investigator, Affiliation: Henri Mondor Hospital
Overall contact: Philippe Lecorvoisier, MD, Phone: +33149813789, Email: philippe.lecorvoisier@hmn.aphp.fr
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).
Clinical Details
Official title: Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Infarct size evaluated by delayed enhancement-magnetic resonance imaging
Secondary outcome: Infarct size/area at risk ratio evaluated by MRIrelease of creatine kinase (CK) and troponin I (TnI) during reperfusion the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion ST segment resolution after reperfusion Left Ventricular Ejection Fraction measured by echocardiography Infarct size measurement by delayed enhancement-magnetic resonance imaging
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Philippe Lecorvoisier, MD, Phone: +33149813789, Email: philippe.lecorvoisier@hmn.aphp.fr
Hopital Privé d'Antony, Antony 92160, France; Withdrawn
Antoine Beclere Hospital, Clamart 92141, France; Withdrawn
Henri Mondor Hospital, Creteil 94010, France; Recruiting Philippe Lecorvoisier, MD, Phone: +33149813789, Email: philippe.lecorvoisier@hmn.aphp.fr Pierre-François Lesault, MD, Sub-Investigator Emmanuel Teiger, MD, PHD, Sub-Investigator Dubois-Randé Jean-Luc, MD, PHD, Sub-Investigator Stéphane Champagne, MD, Sub-Investigator Abdel Belarbi, MD, Sub-Investigator Barnabas Gellen, MD, PHD, Sub-Investigator Gauthier Mouillet, MD, Sub-Investigator Philippe Lecorvoisier, MD, Principal Investigator
Hopital Marie Lannelongue, Plessis Robinson 92350, France; Recruiting Christophe Caussin, PR, Phone: +33140948547, Email: c.caussin@ccml.fr Christophe Caussin, MD, Sub-Investigator Nicolas Amabile, MD, Sub-Investigator Said Ghostine, MD, Sub-Investigator
Additional Information
Starting date: January 2011
Last updated: March 6, 2015
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