The INFUSE - Anterior Myocardial Infarction (AMI) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00976521
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : July 8, 2013
Last Update Posted : July 8, 2013
Information provided by (Responsible Party):
Atrium Medical Corporation

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Acute Anterior Myocardial Infarction Drug: Abciximab local infusion Other: No local infusion Procedure: Thrombus aspiration Not Applicable

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  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Abciximab

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.
Other: No local infusion
Intervention without local infusion

Procedure: Thrombus aspiration
Thrombus aspiration

Active Comparator: No local infusion, no aspiration
No local infusion abciximab and no thrombus aspiration
Other: No local infusion
Intervention without local infusion

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00976521

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Atrium Medical Corporation Identifier: NCT00976521     History of Changes
Other Study ID Numbers: 901
First Posted: September 14, 2009    Key Record Dates
Results First Posted: July 8, 2013
Last Update Posted: July 8, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Anterior Wall Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs