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Trial record 18 of 34 for:    uspio

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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
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

  Show Detailed Description

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
U.S. FDA Resources

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT01995799


Contacts
Contact: Shirjel R Alam, MBChB 0131 536 1000 ext ask for name s.r.alam@sms.ed.ac.uk

Locations
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       scott.semple@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
Investigators
Study Director: Shirjel R Alam, MBChB University of Edinburgh

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01995799     History of Changes
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:
Inflammation
Infarction
Myocardial Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions