Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Inflammation Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Infirmary of Edinburgh, Edinburgh, Midlothian, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferumoxytol

Other

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

Other names: Feraheme; Advanced Magnetics, Inc., Cambridge, MA

Primary outcomes

Change in myocardial T2* magnetic resonance signal

Time frame: 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 outcomes

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

Change in systemic (blood) markers of inflammation over time after myocardial infarction and correlation with T2*weighted MR signal after administration of ferumoxytol.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Mar 25, 2011
Registry last updated: Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed