Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Other: Ferumoxytol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferumoxytol<br>Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning. | Other: Ferumoxytol<br>* One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)<br>* Other names: Feraheme; Advanced Magnetics, Inc., Cambridge, MA;|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in myocardial T2* magnetic resonance signal | Change in T2*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration. | Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Magnetic resonance, Nanoparticle, Iron, Inflammation