Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
NCT ID: NCT01323296
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2010-11-30
2012-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Ferumoxytol
Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.
Ferumoxytol
One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)
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.
No interventions assigned to this group
Interventions
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Ferumoxytol
One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Troponin I ≥ 10 IU/mL at 12 hours after the onset of chest pain
* Age 18 - 80 years inclusive
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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David E Newby, FRCP, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
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Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom
University of Edinburgh
Edinburgh, Midlothian, United Kingdom
Countries
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References
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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.
Other Identifiers
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10/S1103/50 (REC REF)
Identifier Type: -
Identifier Source: org_study_id