Clinical trial NCT01319760: MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction
Official title: MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ST-elevation Myocardial Infarction
Keywords: STEMI
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Infarct Size
timeFrame: 3-5 Days post infarct
measure: No Data for Primary or Secondary Enpoints Were Collected
timeFrame: No data for primary or secondary enpoints were collected
Secondary outcomes:
measure: Infarct Size
timeFrame: 90 Days
Other outcomes:
Locations:
Study officials:
affiliation: Columbia Presbyterian
name: Jeffrey Moses, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia Presbyterian
name: Ajay Kirtane, MD
role: PRINCIPAL_INVESTIGATOR
References: