Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

Myocardial Infarction Clinical Trial

Official title:

Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323296
• Other study ID #: 10/S1103/50 (REC REF)
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: December 3, 2014
• Start date: November 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2010
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: University of Edinburgh
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Midlothian
United Kingdom	University of Edinburgh	Edinburgh	Midlothian

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in myocardial T2* magnetic resonance signal	Change in T2*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.	Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol	No
Secondary	Change in systemic blood markers of inflammation	Change in systemic (blood) markers of inflammation over time after myocardial infarction and correlation with T2*weighted MR signal after administration of ferumoxytol.	Before, 1 day, 2 days, 4 days, 1 week and 1 month after administration of ferumoxytol	No