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Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

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: NCT01323296
Recruitment Status : Completed
First Posted : March 25, 2011
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
The investigators wish to examine whether a novel 'nanoparticle' of iron oxide, administered intravenously allows an area of heart muscle damage after heart attack to be visualised using a magnetic resonance scanner.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: Ferumoxytol Not Applicable

Detailed Description:

Using ferumoxtran (Feraheme) as a USPIO contrast agent for magnetic resonance imaging at 3 Tesla, we aim to conduct the first clinical study to examine the utility of this novel contrast agent to image myocardial inflammation after myocardial infarction.

We will test the following hypotheses in patients who have suffered recent acute myocardial infarction.

  1. Intravenous injection of ferumoxytol accumulates at the site of myocardial infarction and this can be visualised by magnetic resonance imaging.
  2. The spatial extent of the MRI signal change evoked by ferumoxytol in the myocardium is proportional to the volume of infarcted myocardium (as assessed by a gadolinium late-enhancement study).
  3. Myocardial MRI signal change evoked by ferumoxytol is positively correlated with blood markers of systemic inflammation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
Study Start Date : November 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Active Comparator: Ferumoxytol
Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.
Other: Ferumoxytol
One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)
Other Name: Feraheme; Advanced Magnetics, Inc., Cambridge, MA

No Intervention: Control
Subjects who have suffered myocardial infarction will undergo cardiac magnetic resonance imaging at the same time points as those in the 'ferumoxytol' arm but will not receive ferumoxytol or placebo.

Primary Outcome Measures :
  1. Change in myocardial T2* magnetic resonance signal [ Time Frame: Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol ]
    Change in T2*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.

Secondary Outcome Measures :
  1. Change in systemic blood markers of inflammation [ Time Frame: Before, 1 day, 2 days, 4 days, 1 week and 1 month after administration of ferumoxytol ]
    Change in systemic (blood) markers of inflammation over time after myocardial infarction and correlation with T2*weighted MR signal after administration of ferumoxytol.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presentation with myocardial infarction (either 'ST-elevation' myocardial infarction or 'non-ST-elevation' myocardial infarction
  • Troponin I ≥ 10 IU/mL at 12 hours after the onset of chest pain
  • Age 18 - 80 years inclusive

Exclusion Criteria:

  • Known critical (≥95%) left main stem coronary artery disease
  • Continued symptoms of angina at rest or minimal exertion
  • Atrial fibrillation
  • Symptomatic heart failure; Killip Class ≥2.
  • Hepatic failure (Childs-Pugh grade B or C) or renal failure (estimated glomerular filtration rate <25 mL/min)
  • Contraindication to magnetic resonance imaging
  • Past history of systemic iron overload/haemochromatosis
  • Patients with known allergy to dextran- or iron-containing compounds

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): NCT01323296

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United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SA
University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SU
Sponsors and Collaborators
University of Edinburgh
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Principal Investigator: David E Newby, FRCP, PhD University of Edinburgh
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Edinburgh Identifier: NCT01323296    
Other Study ID Numbers: 10/S1103/50 (REC REF)
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: October 2010
Keywords provided by University of Edinburgh:
Myocardial infarction
Magnetic resonance
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ferrosoferric Oxide
Parenteral Nutrition Solutions
Pharmaceutical Solutions