DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 MRI

release 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017