Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

University of Edinburgh

Status: Completed

Conditions: Myocardial Infarction

Treatments: Other: Ferumoxytol

Study type: Interventional

Funder types: Other

Identifiers

NCT01323296

10/S1103/50 (REC REF)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Ferumoxytol

Active Comparator group

Description:

Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.

Treatment:

Other: Ferumoxytol

Control

No Intervention group

Description:

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.