Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01323296

Enrollment

Registered

2011-03-25

Start date

2010-11-30

Completion date

2012-10-31

Last updated

2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Myocardial infarction, Magnetic resonance, Nanoparticle, Iron, Inflammation

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.

Interventions

OTHERFerumoxytol

One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in myocardial T2* magnetic resonance signal	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.

Secondary

Measure	Time frame	Description
Change in systemic blood markers of inflammation	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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026