ST-elevation Myocardial InfarctionMINI-AMINCT01319760
MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction
A study testing Impella 2.5 support in people with ST-elevation Myocardial Infarction, run by Abiomed Inc..
Trial summary
A prospective, randomized, controlled multi-site feasibility trial to assess the potential role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- Impella 2.5 support
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years
- Signed Informed Consent
- Acute anterior STEMI with ≥2 mm of ST-segment elevation in 2 or more contiguous anterior leads or ≥ 4 mm in total in the anterior leads, OR, Large Inferior STEMI with ≥2 mm of ST-segment elevation in 2 or more inferior leads AND EITHER ≥1 mm ST-segment elevation in V1 OR ≥1 mm of ST-segment depression in ≥2 contiguous anterior leads (V1-V3)
- Primary PCI performed within 5 hours of the onset of symptoms
- Patient undergoing emergent primary PCI of one culprit lesion in one major native epicardial coronary vessel
- Successful revascularization of the culprit native coronary artery with TIMI Flow Grade of 3 at the end of PCI
Who cannot join
- Cardiac arrest requiring CPR within 24 hours prior to enrollment
- Current cardiogenic shock
- Left Bundle Branch Block (new or old)
- Atrial fibrillation
- Known history of prior MI
- Prior coronary artery bypass graft surgery
Show all 19Show fewer
- Known mural thrombus in the left ventricle or contraindication to left ventriculography
- Presence of a mechanical aortic valve
- Documented presence of moderate to severe aortic stenosis or moderate to severe aortic insufficiency.
- Known history of severe kidney dysfunction.
- Known contraindication to MRI (implanted metallic or magnetically activated device; claustrophobia, inability to hold breath for 15 seconds).
- History of recent (within 1 month) stroke or TIA
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Administration of fibrinolytic therapy within 24 hours
- Known hypersensitivity or contraindication to any of the following: Heparin, pork or pork products; Aspirin, All of the following: Clopidogrel, Ticlopidine, Prasugrel
- Contrast media Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device.
- Severe peripheral arterial obstructive disease that would preclude the IMPELLA® System placement
- Requirement to treat two or more culprit vessels during primary PCI, or plan for staged coronary revascularization (PCI or CABG) within the next 30 days.
- Inability to place Impella within 6 hours of the onset of symptoms, should patient be randomized to this arm.
About this study
Official title: MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction
A prospective, randomized, controlled multi-site feasibility trial to assess the potential role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI)
Read the detailed description
The primary objective of this study is to evaluate whether the adjunctive use of the IMPELLA® 2.5 System for 24 hours following primary PCI for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care (standard of care). This study is a feasibility study. Therefore, the principal objective is to identify trends in cardiac magnetic resonance imaging (MRI)-based efficacy outcomes between the randomized treatment arms (Impella arm compared standard of care.
- Conditions
- ST-elevation Myocardial Infarction
- Being tested
- Impella 2.5 support, Standard of care (Control)
- Keywords
- STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella 2.5 supportDevice
Also called Impella LP 2.5
Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5
Standard of care (Control)Other
Standard care for STEMI patients post-PCI from ACC/AHA Guidelines
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Sham comparator | Patients in the control arm will be treated with standard of care for post-PCI STEMI patients in accordance with the the 2004 ACC/AHA Guidelines for the Management of Patients with ST-elevation Myocardial Infarction. Receives: Other: Standard of care (Control) |
| Impella 2.5 | Experimental | 24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction. Receives: Device: Impella 2.5 support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct Size
Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).
Measured: 3-5 Days post infarct
No Data for Primary or Secondary Enpoints Were Collected
Measured: No data for primary or secondary enpoints were collected
Secondary outcomes (1)
Infarct Size
Assessment of infarct size and remodeling characteristics at 90 days post-infarct.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Change in business priority
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Abiomed Inc.The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Moses, MD, Principal investigator, Columbia PresbyterianAjay Kirtane, MD, Principal investigator, Columbia Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319760
- Sponsor's protocol ID
- MINI-AMI G100286
- Acronym
- MINI-AMI
- Status last verified
- Apr 2019
- First submitted
- 18 Mar 2011
- Last updated
- 13 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01319760
- Acronym / sponsor ID
- MINI-AMI / MINI-AMI G100286
- Conditions
- ST-elevation Myocardial Infarction
- Keywords
- STEMI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in business priority
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Posted 13 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, randomized, controlled multi-site feasibility trial to assess the potential role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI)
Detailed description
The primary objective of this study is to evaluate whether the adjunctive use of the IMPELLA® 2.5 System for 24 hours following primary PCI for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care (standard of care). This study is a feasibility study. Therefore, the principal objective is to identify trends in cardiac magnetic resonance imaging (MRI)-based efficacy outcomes between the randomized treatment arms (Impella arm compared standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Sham comparator | Other: Standard of care (Control)Patients in the control arm will be treated with standard of care for post-PCI STEMI patients in accordance with the the 2004 ACC/AHA Guidelines for the Management of Patients with ST-elevation Myocardial Infarction. |
| Impella 2.5 | Experimental | Device: Impella 2.5 support24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Signed Informed Consent
- Acute anterior STEMI with ≥2 mm of ST-segment elevation in 2 or more contiguous anterior leads or ≥ 4 mm in total in the anterior leads, OR, Large Inferior STEMI with ≥2 mm of ST-segment elevation in 2 or more inferior leads AND EITHER ≥1 mm ST-segment elevation in V1 OR ≥1 mm of ST-segment depression in ≥2 contiguous anterior leads (V1-V3)
- Primary PCI performed within 5 hours of the onset of symptoms
- Patient undergoing emergent primary PCI of one culprit lesion in one major native epicardial coronary vessel
Key exclusion criteria (19 listed)
- Cardiac arrest requiring CPR within 24 hours prior to enrollment
- Current cardiogenic shock
- Left Bundle Branch Block (new or old)
- Atrial fibrillation
- Known history of prior MI
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 |
|---|---|---|
| Impella 2.5 supportAlso: Impella LP 2.5Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5 | Device | Impella 2.5 |
| Standard of care (Control)Standard care for STEMI patients post-PCI from ACC/AHA Guidelines | Other | Standard of care |
Primary outcome
Infarct Size
Time frame: 3-5 Days post infarct
Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).
No Data for Primary or Secondary Enpoints Were Collected
Time frame: No data for primary or secondary enpoints were collected
1 secondary outcome
Infarct Size
Time frame: 90 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey Moses, MD principal investigator
Columbia Presbyterian
Ajay Kirtane, MD principal investigator
Columbia Presbyterian
Questions about this trial
What is this clinical trial studying?
A study testing Impella 2.5 support in people with ST-elevation Myocardial Infarction, run by Abiomed Inc..
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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 3-5 Days post infarct). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2019.