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IRon Nanoparticle Enhanced MRI in the Assessment of Myocardial infarctioN (IRNMAN)

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: NCT01995799
Recruitment Status : Unknown
Verified November 2013 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
Ferumoxytol is an example of a 'smart' magnetic resonance contrast agent that consists of ultrasmall superparamagnetic particles of iron oxide (USPIOs) and is avidly taken up by macrophages. Through a previous work, the investigators have established that USPIOs can identify inflammation in the wall of abdominal aortic aneurysms and that this is associated with a three-fold increase in the rate of aneurysm growth. The utility of ferumoxytol for imaging cardiovascular inflammation in other areas of the body has yet to be established but Dr Alam has established uptake of USPIOs in the penumbra and infarct zone of the myocardium in patients with a recent myocardial infarction. The investigators wish to assess USPIO uptake in patients with recent acute myocardial infarction and identify the time course and determinants of cellular tissue inflammation. This will be the first clinical study to examine the ability of USPIOs to image myocardial inflammation following acute myocardial infarction.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Inflammation Device: Ferumoxytol enhanced MRI Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ASSESSMENT OF CELLULAR INFLAMMATION FOLLOWING ACUTE MYOCARDIAL INFARCTION Application Of Ultrasmall Superparamagnetic Particles Of Iron Oxide
Study Start Date : June 2013
Estimated Primary Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Iron
Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Experimental: USPIO timepoint 2-4 days
USPIO given 2-4 days post MI Ferumoxytol enhanced MRI
Device: Ferumoxytol enhanced MRI
Ferumoxytol enhanced MRI scan

Experimental: USPIO timepoint 5-7 days
USPIO given 5-7 days post MI Ferumoxytol enhanced MRI
Device: Ferumoxytol enhanced MRI
Ferumoxytol enhanced MRI scan

Experimental: USPIO tiempoint 11-21 days
USPIO given 11-21 days post MI Ferumoxytol enhanced MRI
Device: Ferumoxytol enhanced MRI
Ferumoxytol enhanced MRI scan

Primary Outcome Measures :
  1. R2* value [ Time Frame: MRI 24 hrs after USPIO infusion (regardless of time-point given) ]

    Marker of USPIO uptake (and inflammation) in each cohort after myocardial infarction.

    The USPIO infusion is given at different time-points for each cohort. However only the R2* value on the MRI 24 hours after infusion will constitute the primary end-point

Secondary Outcome Measures :
  1. Serum Inflammatory markers [ Time Frame: 2-104 days post MI ]
    Correlation between blood and MRI inflammatory markers

Other Outcome Measures:
  1. MRI parameters [ Time Frame: 2-104 days ]
    Ejection fraction change over time

  2. MRI parameters [ Time Frame: Baseline and 3 months ]
    Late enhancement volume change

  3. MRI parameter [ Time Frame: Baseline ]
    T2 oedema

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

Inclusion Criteria:

  • >18 years
  • Plasma troponin concentration >5 ng/mL; upper limit of normal 0.04 ng/mL)
  • Acute myocardial infarction defined according to the Universal Definition of myocardial infarction

Exclusion Criteria:

  • Critical (≥95%) left main stem coronary artery stenosis
  • Continued symptoms of angina at rest or minimal exertion
  • Past history of systemic iron overload or haemochromatosis
  • Renal failure (estimated glomerular filtration rate <25 mL/min)
  • Contraindication to magnetic resonance imaging
  • Significant heart failure (Killip class ≥2)
  • 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): NCT01995799

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Contact: Shirjel R Alam, MBChB 0131 536 1000 ext ask for name

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United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SA
Clinical Research Imaging Centre Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4TJ
Contact: Semple   
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
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Study Director: Shirjel R Alam, MBChB University of Edinburgh
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Responsible Party: University of Edinburgh Identifier: NCT01995799    
Other Study ID Numbers: 2013/R/CAR/04
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by University of Edinburgh:
Myocardial Infarction (and related inflammation)
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