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Completed

NCT Number: NCT01186445

Morphine In Acute Myocardial Infarction

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).

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henri Mondor Hospital, Créteil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

morphine chlorhydrate

Drug

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

Other names: Morphine Chlorhydrate Lavoisier

Saline Solution

Drug

3 ml of saline solution , intracoronary injection during reperfusion

Primary outcomes

  1. Infarct size evaluated by delayed enhancement-magnetic resonance imaging

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

Secondary outcomes

  1. Infarct size/area at risk ratio evaluated by MRI

    Time frame: between day 3 and day 5 after AMI

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

    Time frame: during the first 72 hours after reperfusion

    The Area Under the Curve of CK and TnI during reperfusion

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

    Time frame: at day 0

  4. ST segment resolution after reperfusion

    Time frame: during the first 24 hours after reperfusion

  5. Left Ventricular Ejection Fraction measured by echocardiography

    Time frame: at day 1 and day 6

  6. Infarct size measurement by delayed enhancement-magnetic resonance imaging

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

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

Registry information

Official study title

Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction

Acronym: MIAMI

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 23, 2010
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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