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Acute Anterior Myocardial InfarctionNCT00976521

The INFUSE - Anterior Myocardial Infarction (AMI) Study

A study testing Abciximab local infusion, No local infusion and Thrombus aspiration in people with Acute Anterior Myocardial Infarction, run by Atrium Medical Corporation at 38 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Anterior Myocardial Infarction
What is being tested?
Abciximab local infusion, No local infusion and Thrombus aspiration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
38 sitesin 6 countries
Study dates
Sep 2009to Apr 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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).

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

38 sites in 6 countries.

38 sites in 6 countries

United Kingdom9 sites

  • Royal Victoria Hospital, Belfast Trust

    Belfast, BT12 6BA

  • Bristol Heart Institute

    Bristol, BS2 8HW

  • Golden Jubilee National Hospital

    Glasgow, G81 4DY

  • University Hospitals of Leicester - Glenfield Hospital

    Leicester, U.k., LE3 9QP

  • King's College Hospital

    London, U.k., SE5 9RS

  • Manchester Royal Infirmary

    Manchester, U.k., M13 9WL

  • Wythenshawe Hospital

    Manchester, U.k., M23 9LT

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Southampton University Hospital

    Southampton, U.k., SO16 6UD

Other trials in United Kingdom

Poland8 sites

  • Polsko - Amerykańskie Kliniki Serca II Oddział Kardiologiczny American Heart of Poland Sp. z o.o.

    Bielsko-Biala, Poland, 43316

  • Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie, Centrum Interwencyjne Leczenia Chorób Serca i Naczyń

    Krakow, Poland, 31102

  • SPZOZ Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Hemodynamiki i Angiografii

    Krakow, Poland, 31501

  • Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii

    Krakow, 30693

  • Pracownia Hemodynamiki Oddziału Kardiologicznego Wojewódzkiego Centrum Medycyny w Opolu

    Opole, 45418

  • Centrum Kardiologii Inwazyjnej GVM Carint

    Oświęcim, 32600

  • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Pracownia Hemodynamiki I Katedry i Kliniki Kardiologii

    Warsaw, Poland, 2097

  • Instytut Kardiologii im. Prymasa Tysiąclecia Kardynała Stefana Wyszyńskiego,I Samodzielna Pracownia Hemodynamiki

    Warsaw, Poland, 4628

Other trials in Poland

United States7 sites

  • Carolinas Medical Center-SHVI

    Charlotte, North Carolina, 28203

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Moses Cone Vascular Center

    Greensboro, North Carolina, 27401

  • Harrisburg Hospital/ Pinnacle Health

    Harrisburg, Pennsylvania, 17110

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Sentara Virginia Beach General Hospital

    Virginia Beach, Virginia, 23454

Other trials in United States

Germany6 sites

  • Charite- University Medicine Campus Benjamin Franklin

    Berlin, D-12200

  • Klinikum Villingen Kardiologie

    Darmstadt, 64283

  • Facharzt fur Innere Medizin/Kardiologie

    Ludwigshafen, D-67063

  • Universitätsmedizin Mannheim - I. Medizinische Klinik

    Mannheim, Germany, 68167

  • Klinikum der Universität Regensburg

    Regensburg, Germany, 93053

  • Universtitätsklinikuim Ulm

    Ulm, 89081

Other trials in Germany

Austria5 sites

  • Landeskrankenhaus Braunau/Simbach

    Braunau am Inn, 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

Other trials in Austria

Netherlands3 sites

  • Ziekenhuis Rijnstate

    Arnhem, NL, 6815 AD

  • Catharina Hospital Eindhoven

    Eindhoven, 5623 EJ

  • Isala Klinieken, Locatie de Weezenlanden

    Zwolle, 8011 JW

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Abciximab local infusion, No local infusion, Thrombus aspiration
Medical subject headings
Anterior Wall Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abciximab local infusionDrug

    Local infusion of abciximab using the ClearWay™ RX Infusion Catheter

  • No local infusionOther

    Intervention without local infusion

  • Thrombus aspirationProcedure or surgery

    Thrombus aspiration

Study groups in NCT00976521
Study groupRoleWhat they receive
Local infusion, thrombus aspirationExperimentalLocal infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
Receives: Drug: Abciximab local infusion; Procedure: Thrombus aspiration
Local infusion, no aspirationExperimentalLocal infusion of abciximab using the ClearWay™ RX Infusion Catheter and no aspiration
Receives: Drug: Abciximab local infusion
No local infusion, thrombus aspirationActive comparatorNo local infusion of abciximab, thrombus aspiration.
Receives: Other: No local infusion; Procedure: Thrombus aspiration
No local infusion, no aspirationActive comparatorNo local infusion abciximab and no thrombus aspiration
Receives: Other: No local infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion

    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.

    Measured: 30 Days Post Index Procedure

Secondary outcomes (1)

  1. Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration

    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.

    Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionFeb 2012
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976521
Sponsor's protocol ID
901
Status last verified
May 2013
First submitted
11 Sep 2009
Last updated
8 Jul 2013
Data monitoring committee
Yes

Publications

  • Giustino G, Redfors B, Brener SJ, Kirtane AJ, Genereux P, Maehara A, Dudek D, Neunteufl T, Metzger DC, Crowley A, Mehran R, Gibson CM, Stone GW. Correlates and prognostic impact of new-onset heart failure after ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention: insights from the INFUSE-AMI trial. Eur Heart J Acute Cardiovasc Care. 2018 Jun;7(4):339-347. doi: 10.1177/2048872617719649. Epub 2017 Aug 22.

    PubMed 28828881

  • Tomey MI, Mehran R, Brener SJ, Maehara A, Witzenbichler B, Dizon JM, El-Omar M, Xu K, Gibson CM, Stone GW. Sex, adverse cardiac events, and infarct size in anterior myocardial infarction: an analysis of intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction (INFUSE-AMI). Am Heart J. 2015 Jan;169(1):86-93. doi: 10.1016/j.ahj.2014.06.019. Epub 2014 Jul 3.

    PubMed 25497252

  • Guerchicoff A, Brener SJ, Maehara A, Witzenbichler B, Fahy M, Xu K, Gersh BJ, Mehran R, Gibson CM, Stone GW. Impact of delay to reperfusion on reperfusion success, infarct size, and clinical outcomes in patients with ST-segment elevation myocardial infarction: the INFUSE-AMI Trial (INFUSE-Anterior Myocardial Infarction). JACC Cardiovasc Interv. 2014 Jul;7(7):733-40. doi: 10.1016/j.jcin.2014.01.166.

    PubMed 25060015

  • Stone GW, Witzenbichler B, Godlewski J, Dambrink JH, Ochala A, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Dizon JM, Wolff SD, Brener SJ, Mehran R, Maehara A, Gibson CM. Intralesional abciximab and thrombus aspiration in patients with large anterior myocardial infarction: one-year results from the INFUSE-AMI trial. Circ Cardiovasc Interv. 2013 Oct 1;6(5):527-34. doi: 10.1161/CIRCINTERVENTIONS.113.000644. Epub 2013 Oct 1.

    PubMed 24084626

  • Brener SJ, Maehara A, Dizon JM, Fahy M, Witzenbichler B, Parise H, El-Omar M, Dambrink JH, Mehran R, Oldroyd K, Gibson CM, Stone GW. Relationship between myocardial reperfusion, infarct size, and mortality: the INFUSE-AMI (Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial. JACC Cardiovasc Interv. 2013 Jul;6(7):718-24. doi: 10.1016/j.jcin.2013.03.013.

    PubMed 23866184

  • Brener SJ, Witzenbichler B, Maehara A, Dizon J, Fahy M, El-Omar M, Dambrink JH, Genereux P, Mehran R, Oldroyd K, Parise H, Gibson CM, Stone GW. Infarct size and mortality in patients with proximal versus mid left anterior descending artery occlusion: the Intracoronary Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction (INFUSE-AMI) trial. Am Heart J. 2013 Jul;166(1):64-70. doi: 10.1016/j.ahj.2013.03.029. Epub 2013 Apr 30.

    PubMed 23816023

  • Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM; INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012 May 2;307(17):1817-26. doi: 10.1001/jama.2012.421. Epub 2012 Mar 25.

    PubMed 22447888

  • Gibson CM, Maehara A, Lansky AJ, Wohrle J, Stuckey T, Dave R, Cox D, Grines C, Dudek D, Steg G, Parise H, Wolff SD, Cristea E, Stone GW. Rationale and design of the INFUSE-AMI study: A 2 x 2 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. Am Heart J. 2011 Mar;161(3):478-486.e7. doi: 10.1016/j.ahj.2010.10.006. Epub 2011 Jan 28.

    PubMed 21392601

Questions about this trial

What is this clinical trial studying?

A study testing Abciximab local infusion, No local infusion and Thrombus aspiration in people with Acute Anterior Myocardial Infarction, run by Atrium Medical Corporation at 38 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United Kingdom, Poland, United States, Germany, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00976521, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.

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