CompletedPhase 2/3

DEtection of Cellular Inflammation With FERumoxytol in the HEART

United Kingdom58 participantsStarted 2014-12

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. One of the four conditions below:
✓. Age \> 18 years.

Exclusion criteria

✕. Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging safety questionnaire
✕. Patients refusing or unable to give informed consent
✕. Renal failure (estimated glomerular filtration rate \<30 mL/min)
✕. Polycythemia
✕. Contraindication to ferumoxytol (previous allergic drug reaction, any immune or inflammatory conditions (eg, systemic lupus erythematosus, rheumatoid arthritis, history of severe asthma, eczema or other atopic allergy)), evidence of known iron overload, hemochromatosis, known hypersensitivity to ferumoxytol or its components or anaemia not caused by iron deficiency.
✕. Known allergy to dextran- or iron-containing compounds.
✕. Diagnosis of myocardial infarction within 1 month.
✕. Pregnancy or Breast-feeding.

What they're measuring

Assessment of Myocardial Cellular Inflammation.

Timeframe: 1 year

Trial details

NCT IDNCT02319278

SponsorUniversity of Edinburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11

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