The INFUSE - Anterior Myocardial Infarction (AMI) Study

May 31, 2013 updated by: Atrium Medical Corporation

A 2x2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST-Segment Elevation Myocardial Infarction

This is a multicenter, open-label, controlled, single-blind, randomized study with up to 452 subjects enrolled in up to 50 US and European sites. Subjects who present with anterior ST-elevation myocardial infarction (STEMI) and an occluded proximal or mid left anterior descending (LAD) with TIMI 0/1/2 flow will be eligible for randomization to one of the following arms:

  1. Local infusion of abciximab following thrombus aspiration
  2. Local infusion of abciximab and no thrombus aspiration
  3. No local infusion and thrombus aspiration
  4. No local infusion and no thrombus aspiration

In addition, a cardiac magnetic resonance imaging (MRI) sub-study evaluating microvascular obstruction (MVO) will be performed with up to 160 subjects at up to 20 sites.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the study is to demonstrate that among subjects undergoing primary PCI for anterior STEMI treated with a bivalirudin monotherapy anticoagulation strategy, the intracoronary infusion of an abciximab bolus with or without thrombus aspiration prior to stent implantation, compared to no infusion with or without thrombus aspiration (standard of care), results in 1) reduced infarct size measured by cardiac MRI at 30 days (range -7 days/+14 days; i.e., between 23 and 44 days), 2) reduce microvascular obstruction (MVO) by cardiac MRI at 5 + 2 days (i.e., between 3 and 7 days), 3) enhanced ST-segment resolution, 4) improved myocardial perfusion, 5) reduced thrombus burden and angiographic complications, and 6) no increase in major and minor bleeding.

Study Type

Interventional

Enrollment (Actual)

452

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Braunau, Austria, 5280
        • Landeskrankenhaus Braunau/Simbach
      • Bruck/Mur, Austria, 8600
        • Landeskrankenhaus Bruck/Mur
      • Graz, Austria, 8020
        • Landeskrankenhaus Graz West
      • Innsbruck, Austria, 6020
        • Univ. Klinik für Innere Medizin III Innsbruck
      • Vienna, Austria, 1090
        • Univ. Klinik für Innere Medizin II
  • Germany
      • Berlin, Germany, D-12200
        • Charite- University Medicine Campus Benjamin Franklin
      • Darmstadt, Germany, 64283
        • Klinikum Villingen Kardiologie
      • Ludwigshafen, Germany, D-67063
        • Facharzt fur Innere Medizin/Kardiologie
      • Mannheim, Germany, 68167
        • Universitätsmedizin Mannheim - I. Medizinische Klinik
      • Regensburg, Germany, 93053
        • Klinikum der Universität Regensburg
      • Ulm, Germany, 89081
        • Universtitätsklinikuim Ulm
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Hospital Eindhoven
      • Zwolle, Netherlands, 8011 JW
        • Isala Klinieken, Locatie de Weezenlanden
    • NL
      • Arnhem, NL, Netherlands, 6815 AD
        • Ziekenhuis Rijnstate
  • Poland
      • Bielsko-Biała, Poland, 43316
        • Polsko - Amerykańskie Kliniki Serca II Oddział Kardiologiczny American Heart of Poland Sp. z o.o.
      • Krakow, Poland, 30693
        • Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
      • Kraków, Poland, 31102
        • Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie, Centrum Interwencyjne Leczenia Chorób Serca i Naczyń
      • Kraków, Poland, 31501
        • SPZOZ Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Hemodynamiki i Angiografii
      • Opole, Poland, 45418
        • Pracownia Hemodynamiki Oddziału Kardiologicznego Wojewódzkiego Centrum Medycyny w Opolu
      • Oswiecim, Poland, 32600
        • Centrum Kardiologii Inwazyjnej GVM Carint
      • Warszawa, Poland, 2097
        • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Pracownia Hemodynamiki I Katedry i Kliniki Kardiologii
      • Warszawa, Poland, 4628
        • Instytut Kardiologii im. Prymasa Tysiąclecia Kardynała Stefana Wyszyńskiego,I Samodzielna Pracownia Hemodynamiki
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital, Belfast Trust
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Heart Institute
      • Glasgow, United Kingdom, G81 4DY
        • Golden Jubilee National Hospital
      • Newcastle-upon-Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
    • U.k.
      • Leicester, U.k., United Kingdom, LE3 9QP
        • University Hospitals of Leicester - Glenfield Hospital
      • London, U.k., United Kingdom, SE5 9RS
        • King's College Hospital
      • Manchester, U.k., United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Manchester, U.k., United Kingdom, M23 9LT
        • Wythenshawe Hospital
      • Southampton, U.k., United Kingdom, SO16 6UD
        • Southampton University Hospital
  • United States
    • Maryland
      • Takoma Park, Maryland, United States, 20912
        • Washington Adventist Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center-SHVI
      • Greensboro, North Carolina, United States, 27401
        • Moses Cone Vascular Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Harrisburg, Pennsylvania, United States, 17110
        • Harrisburg Hospital/ Pinnacle Health
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont Holston Valley Medical Center
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Sentara Virginia Beach General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • The subject must be >18 years of age;
  • Subject is experiencing clinical symptoms consistent with AMI (e.g., chest pain, arm pain, etc.,) >30 minutes duration and unresponsive to nitroglycerin;
  • Anterior MI with ECG showing at least 1 mm of ST-segment elevation in 2 or more contiguous leads in V1-V4, or new (or presumably new) left bundle branch block;
  • Anticipated symptom onset to balloon or aspiration time of ≤5 hours;
  • The subject and his/her physician are willing to comply with specified follow-up evaluations;
  • The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB)
  • Infarct artery located in the proximal or mid left anterior descending coronary artery, with TIMI 0/1/2 flow at the time of initial diagnostic angiography (prior to wire passage);
  • Based on coronary anatomy, PCI is indicated for revascularization;
  • Only one epicardial coronary artery will be treated;
  • Expected ability to deliver a ClearWay™ RX Infusion Catheter to the infarct lesion (absence of excessive tortuosity, diffuse disease or moderate/heavy calcification).

Key Exclusion Criteria:

  • Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction <40% by any prior measure or regional wall motion abnormalities);
  • An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first twelve months post enrollment;
  • Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the AMI;
  • Subject has previously undergone an angioplasty or stenting procedure in the left anterior descending artery;
  • Definite planned use of aspiration, atherectomy, thrombectomy and/or distal protection catheters prior to PTCA or stent implantation (other than in subjects randomized to thrombus aspiration);
  • Any contraindication to undergo MRI imaging.
  • Multivessel intervention required during the index procedure (subjects may be enrolled if treatment of more than one lesion in the LAD or its branches is required, however) (planned staged procedures are permitted with strong recommendation to be performed after 30-day clinical and MRI endpoints are completed);
  • Severe vessel tortuosity, diffuse disease or severe calcification is present which may impede successful delivery of the ClearWay™ RX Infusion Catheter or the Export® Aspiration Catheter;
  • Features are present highly unfavorable for PCI;
  • Target lesion is present within a bypass graft conduit;
  • MI is due to thrombosis within or adjacent to a previously implanted stent;
  • Left ventriculography demonstrates severe mitral regurgitation or a VSD;
  • Unprotected left main stenosis >40% or that will require intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Local infusion, thrombus aspiration
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
Drug: Abciximab local infusion
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter
Procedure: Thrombus aspiration
Thrombus aspiration
EXPERIMENTAL: Local infusion, no aspiration
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no aspiration
Drug: Abciximab local infusion
Local infusion of abciximab using the ClearWay™ RX Infusion Catheter
ACTIVE_COMPARATOR: No local infusion, thrombus aspiration
No local infusion of abciximab, thrombus aspiration.
Procedure: Thrombus aspiration
Thrombus aspiration
Other: No local infusion
Intervention without local infusion
ACTIVE_COMPARATOR: No local infusion, no aspiration
No local infusion abciximab and no thrombus aspiration
Other: No local infusion
Intervention without local infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion
Time Frame: 30 Days Post Index Procedure
The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.
30 Days Post Index Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration
Time Frame: 30 Days
The major secondary endpoint of the INFUSE AMI Study is infarct size as a percentage of total myocardial mass at 30 days measured by cardiac MRI (cMRI), comparing the pooled randomized aspiration arms to the pooled no aspiration arms, without regard to abciximab infusion.
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atrium Medical Corporation

Investigators

  • Principal Investigator: Greg W Stone, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (ESTIMATE)

September 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2013

Last Update Submitted That Met QC Criteria

May 31, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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