NCT01323296

Brief Summary

The investigators wish to examine whether a novel 'nanoparticle' of iron oxide, administered intravenously allows an area of heart muscle damage after heart attack to be visualised using a magnetic resonance scanner.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 4, 2014

Status Verified

October 1, 2010

Enrollment Period

1.9 years

First QC Date

March 24, 2011

Last Update Submit

December 3, 2014

Conditions

Myocardial Infarction

Keywords

Myocardial infarctionMagnetic resonanceNanoparticleIronInflammation

Outcome Measures

Primary Outcomes (1)

  • Change in myocardial T2* magnetic resonance signal

    Change in T2\*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.

    Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol

Secondary Outcomes (1)

  • Change in systemic blood markers of inflammation

    Before, 1 day, 2 days, 4 days, 1 week and 1 month after administration of ferumoxytol

Study Arms (2)

Ferumoxytol

ACTIVE COMPARATOR

Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.

Other: Ferumoxytol

Control

NO INTERVENTION

Subjects who have suffered myocardial infarction will undergo cardiac magnetic resonance imaging at the same time points as those in the 'ferumoxytol' arm but will not receive ferumoxytol or placebo.

Interventions

FerumoxytolOTHER

One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)

Also known as: Feraheme; Advanced Magnetics, Inc., Cambridge, MA
Ferumoxytol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presentation with myocardial infarction (either 'ST-elevation' myocardial infarction or 'non-ST-elevation' myocardial infarction
  • Troponin I ≥ 10 IU/mL at 12 hours after the onset of chest pain
  • Age 18 - 80 years inclusive

You may not qualify if:

  • Known critical (≥95%) left main stem coronary artery disease
  • Continued symptoms of angina at rest or minimal exertion
  • Atrial fibrillation
  • Symptomatic heart failure; Killip Class ≥2.
  • Hepatic failure (Childs-Pugh grade B or C) or renal failure (estimated glomerular filtration rate \<25 mL/min)
  • Contraindication to magnetic resonance imaging
  • Past history of systemic iron overload/haemochromatosis
  • Patients with known allergy to dextran- or iron-containing compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

University of Edinburgh

Edinburgh, Midlothian, EH16 4SU, United Kingdom

Location

Related Publications (1)

  • Alam SR, Shah AS, Richards J, Lang NN, Barnes G, Joshi N, MacGillivray T, McKillop G, Mirsadraee S, Payne J, Fox KA, Henriksen P, Newby DE, Semple SI. Ultrasmall superparamagnetic particles of iron oxide in patients with acute myocardial infarction: early clinical experience. Circ Cardiovasc Imaging. 2012 Sep 1;5(5):559-65. doi: 10.1161/CIRCIMAGING.112.974907. Epub 2012 Aug 8.

    PMID: 22875883DERIVED

MeSH Terms

Conditions

Myocardial InfarctionInflammation

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsFerrous CompoundsMinerals

Study Officials

  • David E Newby, FRCP, PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2011

First Posted

March 25, 2011

Study Start

November 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 4, 2014

Record last verified: 2010-10

Locations

GB(2)