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

NCT01319760 | Terminated Results DMC

• 1 other identifier: MINI-AMI G100286
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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)

Conditions

ST-elevation Myocardial Infarction

Keywords

STEMI

Outcome Measures

Primary Outcomes (2)

• Infarct Size

  Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).

  3-5 Days post infarct

• No Data for Primary or Secondary Enpoints Were Collected

  No data for primary or secondary enpoints were collected

Secondary Outcomes (1)

• Infarct Size

  90 Days

Study Arms (2)

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.

Other: Standard of care (Control)

Impella 2.5

EXPERIMENTAL

24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction.

Device: Impella 2.5 support

Interventions

Impella 2.5 support DEVICE

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

Also known as: Impella LP 2.5

Impella 2.5

Standard of care (Control) OTHER

Standard care for STEMI patients post-PCI from ACC/AHA Guidelines

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abiomed Inc.: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Study close in roll in phase. Therefore, no comparison data available.

Results Point of Contact

• Title: Dr. Ajay Kirtane
• Organization: Columbia Presbytarian Hospital, NY

akirtane@columbia.edu

212-305-7060

Study Officials

• Jeffrey Moses, MD

  Columbia Presbyterian

  PRINCIPAL INVESTIGATOR

• Ajay Kirtane, MD

  Columbia Presbyterian

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 22, 2011
• Study Start: April 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 13, 2019
• Results First Posted: May 13, 2019

Record last verified: 2019-04