Back to resultsFerumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ferumoxytol
Sponsored by
About this trial
This is an interventional basic science trial for Myocardial Infarction focused on measuring Myocardial infarction, Magnetic resonance, Nanoparticle, Iron, 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
Sites / Locations
- Royal Infirmary of Edinburgh
- University of Edinburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Ferumoxytol
Control
Arm Description
Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.
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.
Outcomes
Primary Outcome Measures
Change in myocardial T2* magnetic resonance signal
Change in T2*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01323296
First Posted
March 24, 2011
Last Updated
December 3, 2014
Sponsor
University of Edinburgh
1. Study Identification
Unique Protocol Identification Number
NCT01323296
Brief Title
Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
Official Title
Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Intravenous injection of ferumoxytol accumulates at the site of myocardial infarction and this can be visualised by magnetic resonance imaging.
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).
Myocardial MRI signal change evoked by ferumoxytol is positively correlated with blood markers of systemic inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial infarction, Magnetic resonance, Nanoparticle, Iron, Inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferumoxytol
Arm Type
Active Comparator
Arm Description
Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme; Advanced Magnetics, Inc., Cambridge, MA
Intervention Description
One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)
Primary Outcome Measure Information:
Title
Change in myocardial T2* magnetic resonance signal
Description
Change in T2*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.
Time Frame
Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol
Secondary Outcome Measure Information:
Title
Change in systemic blood markers of inflammation
Description
Change in systemic (blood) markers of inflammation over time after myocardial infarction and correlation with T2*weighted MR signal after administration of ferumoxytol.
Time Frame
Before, 1 day, 2 days, 4 days, 1 week and 1 month after administration of ferumoxytol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Newby, FRCP, PhD
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
University of Edinburgh
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22875883
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.
Results Reference
derived
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Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
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