Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Other: Ferumoxytol

• Registration Number: NCT01323296
• Lead Sponsor: University of Edinburgh

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.

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-11
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Midlothian, United Kingdom

University of Edinburgh; 🇬🇧 Edinburgh, Midlothian, United Kingdom