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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01186445 |
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Date of registration:
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20/08/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Morphine In Acute Myocardial Infarction
MIAMI |
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Scientific title:
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Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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94 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01186445 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Philippe Lecorvoisier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Henri Mondor Hospital |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Myocardial Infarction
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Intervention(s)
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Drug: saline solution
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Drug: morphine chlorhydrate
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Primary Outcome(s)
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Infarct size evaluated by delayed enhancement-magnetic resonance imaging
[Time Frame: between day 3 and day 5 after acute myocardial infarction (AMI)]
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Secondary Outcome(s)
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the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion
[Time Frame: at day 0]
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Infarct size measurement by delayed enhancement-magnetic resonance imaging
[Time Frame: 1 year]
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Left Ventricular Ejection Fraction measured by echocardiography
[Time Frame: at day 1 and day 6]
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Infarct size/area at risk ratio evaluated by MRI
[Time Frame: between day 3 and day 5 after AMI]
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release of creatine kinase (CK) and troponin I (TnI) during reperfusion
[Time Frame: during the first 72 hours after reperfusion]
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ST segment resolution after reperfusion
[Time Frame: during the first 24 hours after reperfusion]
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Secondary ID(s)
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MIAMI-2008-09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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