Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction|
- Change in myocardial T2* magnetic resonance signal [ Time Frame: Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol ] [ Designated as safety issue: No ]Change in T2*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.
- 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 ] [ Designated as safety issue: No ]Change in systemic (blood) markers of inflammation over time after myocardial infarction and correlation with T2*weighted MR signal after administration of ferumoxytol.
|Study Start Date:||November 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Ferumoxytol
Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.
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.
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.
- Intravenous injection of ferumoxytol accumulates at the site of myocardial infarction and this can be visualised by magnetic resonance imaging.
- 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).
- Myocardial MRI signal change evoked by ferumoxytol is positively correlated with blood markers of systemic inflammation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323296
|Royal Infirmary of Edinburgh|
|Edinburgh, Midlothian, United Kingdom, EH16 4SA|
|University of Edinburgh|
|Edinburgh, Midlothian, United Kingdom, EH16 4SU|
|Principal Investigator:||David E Newby, FRCP, PhD||University of Edinburgh|