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| Name | Class |
|---|---|
| Royal Infirmary of Edinburgh | OTHER |
| Golden Jubilee National Hospital | OTHER_GOV |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
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To non-invasively image myocardial accumulation of ultrasmall superparamagnetic particles of iron oxide (USPIOs) by an increase in R2* values (compared to controls) within the myocardium of patients with:
i. cardiac transplantation ii. acute myocarditis iii. suspected cardiac sarcoidosis
Ferumoxytol is a 'smart' magnetic resonance contrast agent consisting of ultrasmall superparamagnetic particles of iron oxide (USPIOs) that are taken up by macrophages. Concentration of USPIOs within macrophages changes the tissue relaxation properties and this can be detected by magnetic resonance imaging using R2* maps. In a recent early proof-of-concept study, we demonstrated that macrophages could be detected with USPIOs in the penumbra and infarct zone of the myocardium in patients with a recent myocardial infarction. The investigators therefore wish to establish whether USPIOs can be used to identify cellular inflammation within the myocardium in three distinct clinical conditions that currently lack a non-invasive diagnostic imaging test: cardiac allograft rejection, viral myocarditis and cardiac sarcoidosis. If successful, this would not only provide a useful diagnostic test but would also be a method of monitoring disease progression or response to therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myocarditis | Active Comparator |
| |
| Cardiac sarcoid | Active Comparator |
| |
| Cardiac Transplant | Active Comparator |
| |
| Healthy Volunteers | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol | Drug | Infusion following between paired MRI scans |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Myocardial Cellular Inflammation. | Assessment of Myocardial Cellular Inflammation through the increase in R2* value on post USPIO imaging versus baseline imaging. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of R2* values with circulating inflammatory markers | Comparison of circulating inflammatory markers in peripheral blood with myocardial inflammation (seen on cardiac R2* maps) . | 1 year |
| Does clinical condition correlate with inflammation seen on R2* maps. (assessed by reduction in R2* values) |
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Inclusion Criteria:
One of the four conditions below:
Age > 18 years.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Stirrat, MBChB | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | United Kingdom | ||||
| Golden Jubilee National Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31673393 | Derived | Stirrat CG, Alam S, MacGillivray TJ, Gray C, Dweck MR, Jones V, Wallace W, Payne JR, Prasad SK, Gardner RS, Petrie MC, Mirsadraee S, Henriksen P, Newby DE, Semple S. Ferumoxytol-enhanced MRI in patients with prior cardiac transplantation. Open Heart. 2019 Oct 3;6(2):e001115. doi: 10.1136/openhrt-2019-001115. eCollection 2019. | |
| 28986407 |
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| ID | Term |
|---|---|
| D009205 | Myocarditis |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular 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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Does treatment or recovery from these inflammatory myocardial conditions reduce or halt uptake of USPIOs as assessed by reduction in R2* values. |
| 1 year |
| Do higher R2* correlate with poorer outcome? (assessed by deterioration in ejection fraction or increase in late gadolinium enhancement) | Do patients with higher R2* values have worse outcomes assessed by deterioration in ejection fraction or increase in late gadolinium enhancement. | 1 year |
| Glasgow |
| United Kingdom |
| Royal Brompton Hospital | London | United Kingdom |
| Stirrat CG, Alam SR, MacGillivray TJ, Gray CD, Dweck MR, Dibb K, Spath N, Payne JR, Prasad SK, Gardner RS, Mirsadraee S, Henriksen PA, Semple SI, Newby DE. Ferumoxytol-enhanced magnetic resonance imaging in acute myocarditis. Heart. 2018 Feb;104(4):300-305. doi: 10.1136/heartjnl-2017-311688. Epub 2017 Oct 6. |
| 28642288 | Derived | Stirrat CG, Alam SR, MacGillivray TJ, Gray CD, Dweck MR, Raftis J, Jenkins WS, Wallace WA, Pessotto R, Lim KH, Mirsadraee S, Henriksen PA, Semple SI, Newby DE. Ferumoxytol-enhanced magnetic resonance imaging assessing inflammation after myocardial infarction. Heart. 2017 Oct;103(19):1528-1535. doi: 10.1136/heartjnl-2016-311018. Epub 2017 Jun 22. |
| 27465647 | Derived | Stirrat CG, Alam SR, MacGillivray TJ, Gray CD, Forsythe R, Dweck MR, Payne JR, Prasad SK, Petrie MC, Gardner RS, Mirsadraee S, Henriksen PA, Newby DE, Semple SI. Ferumoxytol-enhanced magnetic resonance imaging methodology and normal values at 1.5 and 3T. J Cardiovasc Magn Reson. 2016 Jul 27;18(1):46. doi: 10.1186/s12968-016-0261-2. |
| D008903 |
| Minerals |