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

Primary Purpose

Cardiac Transplant, Cardiac Sarcoid, Myocarditis

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Ferumoxytol
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 If use of reliable contraception cannot be confirmed, the participant will be withdrawn.

Sites / Locations

  • Royal Infirmary of Edinburgh
  • Golden Jubilee National Hospital
  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Myocarditis

Cardiac sarcoid

Cardiac Transplant

Healthy Volunteers

Arm Description

Outcomes

Primary Outcome Measures

Assessment of Myocardial Cellular Inflammation.
Assessment of Myocardial Cellular Inflammation through the increase in R2* value on post USPIO imaging versus baseline imaging.

Secondary Outcome Measures

Correlation of R2* values with circulating inflammatory markers
Comparison of circulating inflammatory markers in peripheral blood with myocardial inflammation (seen on cardiac R2* maps) .
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.
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.

Full Information

First Posted
December 3, 2014
Last Updated
May 2, 2017
Sponsor
University of Edinburgh
Collaborators
Royal Infirmary of Edinburgh, Golden Jubilee National Hospital, Royal Brompton & Harefield NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02319278
Brief Title
DEtection of Cellular Inflammation With FERumoxytol in the HEART
Acronym
DECIFER
Official Title
DEtection of Cellular Inflammation With FERumoxytol in the HEART
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
Royal Infirmary of Edinburgh, Golden Jubilee National Hospital, Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Transplant, Cardiac Sarcoid, Myocarditis, Healthy Volunteers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myocarditis
Arm Type
Active Comparator
Arm Title
Cardiac sarcoid
Arm Type
Active Comparator
Arm Title
Cardiac Transplant
Arm Type
Active Comparator
Arm Title
Healthy Volunteers
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Intervention Description
Infusion following between paired MRI scans
Primary Outcome Measure Information:
Title
Assessment of Myocardial Cellular Inflammation.
Description
Assessment of Myocardial Cellular Inflammation through the increase in R2* value on post USPIO imaging versus baseline imaging.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Correlation of R2* values with circulating inflammatory markers
Description
Comparison of circulating inflammatory markers in peripheral blood with myocardial inflammation (seen on cardiac R2* maps) .
Time Frame
1 year
Title
Does clinical condition correlate with inflammation seen on R2* maps. (assessed by reduction in R2* values)
Description
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
Title
Do higher R2* correlate with poorer outcome? (assessed by deterioration in ejection fraction or increase in late gadolinium enhancement)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Stirrat, MBChB
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
Country
United Kingdom
Facility Name
Golden Jubilee National Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31673393
Citation
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.
Results Reference
derived
PubMed Identifier
28986407
Citation
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.
Results Reference
derived
PubMed Identifier
28642288
Citation
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.
Results Reference
derived
PubMed Identifier
27465647
Citation
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.
Results Reference
derived

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DEtection of Cellular Inflammation With FERumoxytol in the HEART

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