NCT01319760

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ST-elevation Myocardial Infarction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-03-22
• Last updated: 2019-05-13
• Results posted: 2019-05-13