Overview

DEtection of Cellular Inflammation With FERumoxytol in the HEART

Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Edinburgh
Collaborators:
Golden Jubilee National Hospital
Royal Brompton & Harefield NHS Foundation Trust
Royal Infirmary of Edinburgh
Treatments:
Ferrosoferric Oxide
Criteria
Inclusion Criteria:

1. One of the four conditions below:

- Patients having undergone cardiac transplant

- Patients diagnosed clinically with myocarditis of any aetiology (eg viral,
septic, post chemotherapeutic etc)

- Patients clinically diagnosed with cardiac sarcoidosis

- Healthy volunteers

2. Age > 18 years.

Exclusion Criteria:

1. Contraindication to magnetic resonance imaging scanning identified from magnetic
resonance imaging safety questionnaire

2. Patients refusing or unable to give informed consent

3. Renal failure (estimated glomerular filtration rate <30 mL/min)

4. Polycythemia

5. 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.

6. Known allergy to dextran- or iron-containing compounds.

7. Diagnosis of myocardial infarction within 1 month.

8. Pregnancy or Breast-feeding.

9. Women of child bearing age not ensuring reliable methods of contraception. Female
participants of child bearing age will be asked if they are ensuring reliable methods
of contraception prior to each administration of USPIO and MRI scan. If use of
reliable contraception cannot be confirmed, the participant will be withdrawn.