ST-elevation Myocardial Infarction
Conditions
Keywords
STEMI
Brief 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)
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.
Interventions
DEVICEImpella 2.5 support
Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5
Standard care for STEMI patients post-PCI from ACC/AHA Guidelines
Sponsors
Abiomed Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct Size | 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 | No data for primary or secondary enpoints were collected | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infarct Size | 90 Days | Assessment of infarct size and remodeling characteristics at 90 days post-infarct. |
Participant flow
Recruitment details
Five roll-in subjects were enrolled in the MINI-AMI feasibility study between September 14, 2011 and April 24, 2012. A total of 82 patients have been screened but not enrolled by participating sites during the study period. Five (5) sites participated in the MINI-AMI study.
Pre-assignment details
The study experienced a very low enrollment rate (lower than expected). The study was terminated before the roll-in phase was completed. No data for primary or secondary endpoints were collected in this study
Participants by arm
| Arm | Count |
|---|---|
| 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.
Control: Standard care for STEMI patients post-PCI from ACC/AHA Guidelines | 0 |
| Impella 2.5 Patients in this arm will be treated in accordance with standard of care, and in addition will receive 24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction.
Impella 2.5 support: Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5 | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Impella 2.5 | Total |
|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 10.9 | 61.8 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 5 |
| other Total, other adverse events | 4 / 5 |
| serious Total, serious adverse events | 3 / 5 |
Outcome results
Primary
Infarct Size
Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).
Time frame: 3-5 Days post infarct
Population: No data for primary or secondary endpoints were collected in this study
Primary
No Data for Primary or Secondary Enpoints Were Collected
Time frame: No data for primary or secondary enpoints were collected
Population: No data from primary or secondary endpoints were collected in this study
Secondary
Infarct Size
Assessment of infarct size and remodeling characteristics at 90 days post-infarct.
Time frame: 90 Days
Population: No data for primary or secondary endpoints were collected in this study