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DEtection of Cellular Inflammation With FERumoxytol in the HEART (DECIFER)

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ClinicalTrials.gov Identifier: NCT02319278
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
Royal Infirmary of Edinburgh
Golden Jubilee National Hospital
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
University of Edinburgh

Brief 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


Condition or disease Intervention/treatment Phase
Cardiac Transplant Cardiac Sarcoid Myocarditis Healthy Volunteers Drug: Ferumoxytol Phase 2 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: DEtection of Cellular Inflammation With FERumoxytol in the HEART
Actual Study Start Date : December 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Active Comparator: Myocarditis Drug: Ferumoxytol
Infusion following between paired MRI scans

Active Comparator: Cardiac sarcoid Drug: Ferumoxytol
Infusion following between paired MRI scans

Active Comparator: Cardiac Transplant Drug: Ferumoxytol
Infusion following between paired MRI scans

Placebo Comparator: Healthy Volunteers Drug: Ferumoxytol
Infusion following between paired MRI scans




Primary Outcome Measures :
  1. Assessment of Myocardial Cellular Inflammation. [ Time Frame: 1 year ]
    Assessment of Myocardial Cellular Inflammation through the increase in R2* value on post USPIO imaging versus baseline imaging.


Secondary Outcome Measures :
  1. Correlation of R2* values with circulating inflammatory markers [ Time Frame: 1 year ]
    Comparison of circulating inflammatory markers in peripheral blood with myocardial inflammation (seen on cardiac R2* maps) .

  2. Does clinical condition correlate with inflammation seen on R2* maps. (assessed by reduction in R2* values) [ Time Frame: 1 year ]
    Does treatment or recovery from these inflammatory myocardial conditions reduce or halt uptake of USPIOs as assessed by reduction in R2* values.

  3. Do higher R2* correlate with poorer outcome? (assessed by deterioration in ejection fraction or increase in late gadolinium enhancement) [ Time Frame: 1 year ]
    Do patients with higher R2* values have worse outcomes assessed by deterioration in ejection fraction or increase in late gadolinium enhancement.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319278


Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Royal Brompton Hospital
London, United Kingdom
Sponsors and Collaborators
University of Edinburgh
Royal Infirmary of Edinburgh
Golden Jubilee National Hospital
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Colin Stirrat, MBChB University of Edinburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02319278     History of Changes
Other Study ID Numbers: 2013-002336-24
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Inflammation
Myocarditis
Pathologic Processes
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions