NCT01186445

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

5.9 years

First QC Date

August 20, 2010

Last Update Submit

February 3, 2017

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial InfarctionCardioprotective effectPharmacological postconditioningMorphine ChlorhydrateCardiac MRI

Outcome Measures

Primary Outcomes (1)

  • Infarct size evaluated by delayed enhancement-magnetic resonance imaging

    between day 3 and day 5 after acute myocardial infarction (AMI)

Secondary Outcomes (6)

  • Infarct size/area at risk ratio evaluated by MRI

    between day 3 and day 5 after AMI

  • release of creatine kinase (CK) and troponin I (TnI) during reperfusion

    during the first 72 hours after reperfusion

  • the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion

    at day 0

  • ST segment resolution after reperfusion

    during the first 24 hours after reperfusion

  • Left Ventricular Ejection Fraction measured by echocardiography

    at day 1 and day 6

  • +1 more secondary outcomes

Study Arms (2)

Morphine chlorhydrate

EXPERIMENTAL

Intracoronary injection of morphine chlorhydrate during reperfusion

Drug: morphine chlorhydrate

Saline solution

PLACEBO COMPARATOR

Intracoronary injection of saline solution during reperfusion

Drug: saline solution

Interventions

morphine chlorhydrateDRUG

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

Also known as: Morphine Chlorhydrate Lavoisier
Morphine chlorhydrate
saline solutionDRUG

3 ml of saline solution , intracoronary injection during reperfusion

Saline solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Fibrinolysis
  • Allergy to morphine
  • Active epilepsy
  • Brain injury or intracranial hypertension
  • Previous AMI, coronary artery bypass graft (CABG)
  • Cardiac arrest
  • chronic hepatocellular failure
  • MRI contraindications
  • Gadolinium chelates injection contraindications
  • Current treatment with morphine chlorhydrate, buprenorphine, nalbuphine, pentazocine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henri Mondor Hospital

Créteil, 94010, France

Location

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Related Publications (1)

  • 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.

    PMID: 30340532DERIVED

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Philippe Lecorvoisier, MD

    Henri Mondor University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2010

First Posted

August 23, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 6, 2017

Record last verified: 2017-02

Locations

FR(2)