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Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

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

Tracking Information
First Submitted Date  ICMJE March 24, 2011
First Posted Date  ICMJE March 25, 2011
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE November 2010
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
Official Title  ICMJE Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Ferumoxytol
    Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.
    Intervention: Other: Ferumoxytol
  • 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.
Publications * Alam SR, Shah AS, Richards J, Lang NN, Barnes G, Joshi N, MacGillivray T, McKillop G, Mirsadraee S, Payne J, Fox KA, Henriksen P, Newby DE, Semple SI. Ultrasmall superparamagnetic particles of iron oxide in patients with acute myocardial infarction: early clinical experience. Circ Cardiovasc Imaging. 2012 Sep 1;5(5):559-65. Epub 2012 Aug 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2014)
15
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2011)
18
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01323296
Other Study ID Numbers  ICMJE 10/S1103/50 (REC REF)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David E Newby, FRCP, PhD University of Edinburgh
PRS Account University of Edinburgh
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP