Acute Myocardial InfarctionPhase 3MIAMINCT01186445
Morphine In Acute Myocardial Infarction
A Phase 3 study testing morphine chlorhydrate and saline solution in people with Acute Myocardial Infarction, run by French Cardiology Society at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- morphine chlorhydrate and saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2011to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Fibrinolysis
- Allergy to morphine
- Active epilepsy
- Brain injury or intracranial hypertension
- Previous AMI, coronary artery bypass graft (CABG)
- Cardiac arrest
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Henri Mondor Hospital
Créteil, 94010
Hopital Marie Lannelongue
Le Plessis-Robinson, 92350
About this study
Official title: Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion 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).
- Conditions
- Acute Myocardial Infarction
- Being tested
- morphine chlorhydrate, saline solution
- Keywords
- Acute Myocardial Infarction, Cardioprotective effect, Pharmacological postconditioning, Morphine Chlorhydrate, Cardiac MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphine chlorhydrateDrug
Also called Morphine Chlorhydrate Lavoisier
1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion
saline solutionDrug
3 ml of saline solution , intracoronary injection during reperfusion
| Study group | Role | What they receive |
|---|---|---|
| Morphine chlorhydrate | Experimental | Intracoronary injection of morphine chlorhydrate during reperfusion Receives: Drug: morphine chlorhydrate |
| Saline solution | Placebo comparator | Intracoronary injection of saline solution during reperfusion Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size evaluated by delayed enhancement-magnetic resonance imaging
Measured: between day 3 and day 5 after acute myocardial infarction (AMI)
Secondary outcomes (6)
Infarct size/area at risk ratio evaluated by MRI
Measured: between day 3 and day 5 after AMI
release of creatine kinase (CK) and troponin I (TnI) during reperfusion
The Area Under the Curve of CK and TnI during reperfusion
Measured: during the first 72 hours after reperfusion
the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion
Measured: at day 0
ST segment resolution after reperfusion
Measured: during the first 24 hours after reperfusion
Left Ventricular Ejection Fraction measured by echocardiography
Measured: at day 1 and day 6
Infarct size measurement by delayed enhancement-magnetic resonance imaging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Lecorvoisier, MD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186445
- Sponsor's protocol ID
- MIAMI-2008-09
- Acronym
- MIAMI
- Status last verified
- Feb 2017
- First submitted
- 20 Aug 2010
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30340532
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01186445
- Acronym / sponsor ID
- MIAMI / MIAMI-2008-09
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, Cardioprotective effect, Pharmacological postconditioning, Morphine Chlorhydrate, Cardiac MRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine chlorhydrate | Experimental | Drug: morphine chlorhydrateIntracoronary injection of morphine chlorhydrate during reperfusion |
| Saline solution | Placebo comparator | Drug: saline solutionIntracoronary injection of saline solution during reperfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Acute Myocardial Infarction less than 6 hours defined by
- Culprit lesion eligible for percutaneous coronary intervention (PCI)
- TIMI flow 0 before PCI
Key exclusion criteria (14 listed)
- Fibrinolysis
- Allergy to morphine
- Active epilepsy
- Brain injury or intracranial hypertension
- Previous AMI, coronary artery bypass graft (CABG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morphine chlorhydrateAlso: Morphine Chlorhydrate Lavoisier1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion | Drug | Morphine chlorhydrate |
| saline solution3 ml of saline solution , intracoronary injection during reperfusion | Drug | Saline solution |
Primary outcome
Infarct size evaluated by delayed enhancement-magnetic resonance imaging
Time frame: between day 3 and day 5 after acute myocardial infarction (AMI)
6 secondary outcomes
Infarct size/area at risk ratio evaluated by MRI
Time frame: between day 3 and day 5 after AMI
release of creatine kinase (CK) and troponin I (TnI) during reperfusion
Time frame: during the first 72 hours after reperfusion
the Thrombolysis In Myocardial Infarction (TIMI) myocardial Blush after reperfusion
Time frame: at day 0
ST segment resolution after reperfusion
Time frame: during the first 24 hours after reperfusion
Left Ventricular Ejection Fraction measured by echocardiography
Time frame: at day 1 and day 6
Infarct size measurement by delayed enhancement-magnetic resonance imaging
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Derived from this study: PubMed 30340532Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Lecorvoisier, MD principal investigator
Henri Mondor University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing morphine chlorhydrate and saline solution in people with Acute Myocardial Infarction, run by French Cardiology Society at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size evaluated by delayed enhancement-magnetic resonance imaging (time frame: between day 3 and day 5 after acute myocardial infarction (AMI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01186445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.