Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

December 3, 2014 updated by: University of Edinburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Edinburgh, Midlothian, United Kingdom, EH16 4SU
        • University of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ferumoxytol
Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.
Other: Ferumoxytol
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
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before, 1 day, 2 days, 4 days, 1 week and 1 month after administration of ferumoxytol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Investigators

  • Principal Investigator: David E Newby, FRCP, PhD, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

March 24, 2011

First Posted (Estimate)

March 25, 2011

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/S1103/50 (REC REF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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