A Phase 2/3 interventional study of Ferumoxytol in Cardiac Transplant, Cardiac Sarcoid and Myocarditis, sponsored by University of Edinburgh. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-03.
Sponsored by University of Edinburgh · Phase 2/3, Interventional, and Diagnostic
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.
164 studies on the registry are indexed under Myocarditis; 71 are open to participants now.
This study's enrollment of 58 is below the median of 77 across 48 interventional studies indexed under Myocarditis.
Browse Myocarditis studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
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One of the four conditions below:
Exclusion Criteria:
Drug: Ferumoxytol
Drug: Ferumoxytol
Drug: Ferumoxytol
Drug: Ferumoxytol
Infusion following between paired MRI scans
Assessment of Myocardial Cellular Inflammation.
Assessment of Myocardial Cellular Inflammation through the increase in R2\* value on post USPIO imaging versus baseline imaging.
Time frame: 1 year
Correlation of R2* values with circulating inflammatory markers
Comparison of circulating inflammatory markers in peripheral blood with myocardial inflammation (seen on cardiac R2\* maps) .
Time frame: 1 year
Does clinical condition correlate with inflammation seen on R2* maps. (assessed by reduction in R2* values)
Does treatment or recovery from these inflammatory myocardial conditions reduce or halt uptake of USPIOs as assessed by reduction in R2\* values.
Time frame: 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.
Time frame: 1 year
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of Edinburgh