Morphine In Acute Myocardial Infarction (MIAMI)
This study is currently recruiting participants.
Verified October 2012 by French Cardiology Society
Sponsor:
French Cardiology Society
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01186445
First received: August 20, 2010
Last updated: February 26, 2013
Last verified: October 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction |
Drug: morphine chlorhydrate Drug: saline solution |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction |
Resource links provided by NLM:
Further study details as provided by French Cardiology Society:
Primary Outcome Measures:
- Infarct size evaluated by delayed enhancement-magnetic resonance imaging [ Time Frame: between day 3 and day 5 after acute myocardial infarction (AMI) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Infarct size/area at risk ratio evaluated by MRI [ Time Frame: between day 3 and day 5 after AMI ] [ Designated as safety issue: No ]
- release of creatine kinase (CK) and troponin I (TnI) during reperfusion [ Time Frame: during the first 72 hours after reperfusion ] [ Designated as safety issue: No ]The Area Under the Curve of CK and TnI during reperfusion
- the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion [ Time Frame: at day 0 ] [ Designated as safety issue: No ]
- ST segment resolution after reperfusion [ Time Frame: during the first 24 hours after reperfusion ] [ Designated as safety issue: No ]
- Left Ventricular Ejection Fraction measured by echocardiography [ Time Frame: at day 1 and day 6 ] [ Designated as safety issue: No ]
- Infarct size measurement by delayed enhancement-magnetic resonance imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 94 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Morphine chlorhydrate
Intracoronary injection of morphine chlorhydrate during reperfusion
|
Drug: morphine chlorhydrate
1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion
Other Name: Morphine Chlorhydrate Lavoisier
|
|
Placebo Comparator: Saline solution
Intracoronary injection of saline solution during reperfusion
|
Drug: saline solution
3 ml of saline solution , intracoronary injection during reperfusion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Acute Myocardial Infarction less than 6 hours defined by
- prolonged chest pain (>15 min)
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
- Culprit lesion eligible for percutaneous coronary intervention (PCI)
- TIMI flow 0 before PCI
Exclusion Criteria:
- Fibrinolysis
- Allergy to morphine
- Active epilepsy
- Brain injury or intracranial hypertension
- Previous AMI, coronary artery bypass graft (CABG)
- Cardiac arrest
- Cardiogenic shock, significant mitral regurgitation or intraventricular communication at inclusion
- Mechanical ventilation at inclusion
- Significant ventricular arrhythmia or atrioventricular block type II or III at inclusion
- Decompensated chronic obstructive pulmonary disease at inclusion
- chronic hepatocellular failure
- MRI contraindications
- Gadolinium chelates injection contraindications
- Current treatment with morphine chlorhydrate, buprenorphine, nalbuphine, pentazocine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186445
Contacts
| Contact: Philippe Lecorvoisier, MD | +33149813789 | philippe.lecorvoisier@hmn.aphp.fr |
| Contact: Anissa Bouzamondo, MD | +33143221379 | anissa.bouzamondo@cardio-sfc.org |
Locations
| France | |
| Hopital Privé d'Antony | Withdrawn |
| Antony, France, 92160 | |
| Antoine Beclere Hospital | Withdrawn |
| Clamart, France, 92141 | |
| Henri Mondor Hospital | Recruiting |
| Creteil, France, 94010 | |
| Contact: Philippe Lecorvoisier, MD +33149813789 philippe.lecorvoisier@hmn.aphp.fr | |
| Sub-Investigator: 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 | |
| Principal Investigator: Philippe Lecorvoisier, MD | |
| Hopital Marie Lannelongue | Recruiting |
| Plessis Robinson, France, 92350 | |
| Contact: Christophe Caussin, PR +33140948547 c.caussin@ccml.fr | |
| Sub-Investigator: Christophe Caussin, MD | |
| Sub-Investigator: Nicolas Amabile, MD | |
| Sub-Investigator: Said Ghostine, MD | |
Sponsors and Collaborators
French Cardiology Society
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
| Principal Investigator: | Philippe Lecorvoisier, MD | Henri Mondor Hospital |
More Information
No publications provided
| Responsible Party: | French Cardiology Society |
| ClinicalTrials.gov Identifier: | NCT01186445 History of Changes |
| Other Study ID Numbers: | MIAMI-2008-09 |
| Study First Received: | August 20, 2010 |
| Last Updated: | February 26, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French Cardiology Society:
|
Acute Myocardial Infarction Cardioprotective effect Pharmacological postconditioning Morphine Chlorhydrate Cardiac MRI |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Morphine |
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on June 17, 2013