MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction

ST-elevation Myocardial Infarction Clinical Trial

— MINI-AMI  

Official title:

MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01319760
• Other study ID #: MINI-AMI G100286
• Status: Terminated
• Phase: N/A
• Start date: April 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2019
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

Device:
• Impella 2.5 support
Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5

Other:
• Standard of care (Control)
Standard care for STEMI patients post-PCI from ACC/AHA Guidelines

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct Size	Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).	3-5 Days post infarct
Primary	No Data for Primary or Secondary Enpoints Were Collected		No data for primary or secondary enpoints were collected
Secondary	Infarct Size	Assessment of infarct size and remodeling characteristics at 90 days post-infarct.	90 Days