DEtection of Cellular Inflammation With FERumoxytol in the HEART

NCT02319278 | Completed Phase 2

• 1 other identifier: 2013-002336-24
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

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

Conditions

Cardiac Transplant; Cardiac Sarcoid; Myocarditis; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Assessment of Myocardial Cellular Inflammation.

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

  1 year

Secondary Outcomes (3)

• Correlation of R2* values with circulating inflammatory markers

  1 year

• Does clinical condition correlate with inflammation seen on R2* maps. (assessed by reduction in R2* values)

  1 year

• Do higher R2* correlate with poorer outcome? (assessed by deterioration in ejection fraction or increase in late gadolinium enhancement)

  1 year

Study Arms (4)

Myocarditis

ACTIVE COMPARATOR

Drug: Ferumoxytol

Cardiac sarcoid

ACTIVE COMPARATOR

Drug: Ferumoxytol

Cardiac Transplant

ACTIVE COMPARATOR

Drug: Ferumoxytol

Healthy Volunteers

PLACEBO COMPARATOR

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

Infusion following between paired MRI scans

Cardiac Transplant; Cardiac sarcoid; Healthy Volunteers; Myocarditis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• Royal Infirmary of Edinburgh: collaborator
• Golden Jubilee National Hospital: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (3)

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 31673393 DERIVED

• 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.

  PMID: 28986407 DERIVED

• 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.

  PMID: 28642288 DERIVED

• 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.

  PMID: 27465647 DERIVED

MeSH Terms

Conditions

Myocarditis

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Colin Stirrat, MBChB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 18, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

GB (3)