Clinical trial NCT01323296: Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
Official title: Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
Magnetic resonance
Nanoparticle
Iron
Inflammation
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in myocardial T2* magnetic resonance signal
timeFrame: Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol
Secondary outcomes:
measure: Change in systemic blood markers of inflammation
timeFrame: Before, 1 day, 2 days, 4 days, 1 week and 1 month after administration of ferumoxytol
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Midlothian
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
state: Midlothian
Study officials:
affiliation: University of Edinburgh
name: David E Newby, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alam SR, Shah AS, Richards J, Lang NN, Barnes G, Joshi N, MacGillivray T, McKillop G, Mirsadraee S, Payne J, Fox KA, Henriksen P, Newby DE, Semple SI. Ultrasmall superparamagnetic particles of iron oxide in patients with acute myocardial infarction: early clinical experience. Circ Cardiovasc Imaging. 2012 Sep 1;5(5):559-65. doi: 10.1161/CIRCIMAGING.112.974907. Epub 2012 Aug 8.