Morphine In Acute Myocardial Infarction

NCT ID: NCT01186445

Last Updated: 2017-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Morphine chlorhydrate

Intracoronary injection of morphine chlorhydrate during reperfusion

Group Type EXPERIMENTAL

morphine chlorhydrate

Intervention Type DRUG

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

Saline solution

Intracoronary injection of saline solution during reperfusion

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type DRUG

3 ml of saline solution , intracoronary injection during reperfusion

Interventions

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morphine chlorhydrate

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

Intervention Type DRUG

saline solution

3 ml of saline solution , intracoronary injection during reperfusion

Intervention Type DRUG

Other Intervention Names

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Morphine Chlorhydrate Lavoisier

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Lecorvoisier, MD

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor University Hospital

Locations

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Henri Mondor Hospital

Créteil, , France

Site Status

Hopital Marie Lannelongue

Le Plessis-Robinson, , France

Site Status

Countries

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France

References

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Le Corvoisier P, Gallet R, Lesault PF, Audureau E, Paul M, Ternacle J, Ghostine S, Champagne S, Arrouasse R, Bitari D, Mouillet G, Dubois-Rande JL, Berdeaux A, Ghaleh B, Deux JF, Teiger E. Intra-coronary morphine versus placebo in the treatment of acute ST-segment elevation myocardial infarction: the MIAMI randomized controlled trial. BMC Cardiovasc Disord. 2018 Oct 19;18(1):193. doi: 10.1186/s12872-018-0936-8.

Reference Type DERIVED
PMID: 30340532 (View on PubMed)

Other Identifiers

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MIAMI-2008-09

Identifier Type: -

Identifier Source: org_study_id

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