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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxytol | Active Comparator | Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning. |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol | Other | One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Newby, FRCP, PhD | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | Midlothian | EH16 4SA | United Kingdom | ||
| University of Edinburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22875883 | Derived | 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. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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| Edinburgh |
| Midlothian |
| EH16 4SU |
| United Kingdom |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D008903 |
| Minerals |