Myocardial InfarctionNCT01323296
Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
A study testing Ferumoxytol in people with Myocardial Infarction, run by University of Edinburgh at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Ferumoxytol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
University of Edinburgh
Edinburgh, Midlothian, EH16 4SU
About this study
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.
Read the detailed description
Using ferumoxtran (Feraheme) as a USPIO contrast agent for magnetic resonance imaging at 3 Tesla, we aim to conduct the first clinical study to examine the utility of this novel contrast agent to image myocardial inflammation after myocardial infarction.
We will test the following hypotheses in patients who have suffered recent acute myocardial infarction.
- Intravenous injection of ferumoxytol accumulates at the site of myocardial infarction and this can be visualised by magnetic resonance imaging.
- The spatial extent of the MRI signal change evoked by ferumoxytol in the myocardium is proportional to the volume of infarcted myocardium (as assessed by a gadolinium late-enhancement study).
- Myocardial MRI signal change evoked by ferumoxytol is positively correlated with blood markers of systemic inflammation.
- Conditions
- Myocardial Infarction
- Being tested
- Ferumoxytol
- Keywords
- Myocardial infarction, Magnetic resonance, Nanoparticle, Iron, Inflammation
- Medical subject headings
- Myocardial Infarction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolOther
Also called Feraheme; Advanced Magnetics, Inc., Cambridge, MA
One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxytol | Active comparator | Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myocardial T2* magnetic resonance signal
Change in T2*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.
Measured: Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol
Secondary outcomes (1)
Change in systemic blood markers of inflammation
Change in systemic (blood) markers of inflammation over time after myocardial infarction and correlation with T2*weighted MR signal after administration of ferumoxytol.
Measured: Before, 1 day, 2 days, 4 days, 1 week and 1 month after administration of ferumoxytol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David E Newby, FRCP, PhD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323296
- Sponsor's protocol ID
- 10/S1103/50 (REC REF)
- Status last verified
- Oct 2010
- First submitted
- 24 Mar 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22875883
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01323296
- Acronym / sponsor ID
- 10/S1103/50 (REC REF)
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, Magnetic resonance, Nanoparticle, Iron, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Using ferumoxtran (Feraheme) as a USPIO contrast agent for magnetic resonance imaging at 3 Tesla, we aim to conduct the first clinical study to examine the utility of this novel contrast agent to image myocardial inflammation after myocardial infarction.
We will test the following hypotheses in patients who have suffered recent acute myocardial infarction.
- Intravenous injection of ferumoxytol accumulates at the site of myocardial infarction and this can be visualised by magnetic resonance imaging.
- The spatial extent of the MRI signal change evoked by ferumoxytol in the myocardium is proportional to the volume of infarcted myocardium (as assessed by a gadolinium late-enhancement study).
- Myocardial MRI signal change evoked by ferumoxytol is positively correlated with blood markers of systemic inflammation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferumoxytol | Active comparator | Other: FerumoxytolPatients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerumoxytolAlso: Feraheme; Advanced Magnetics, Inc., Cambridge, MAOne dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec) | Other | Ferumoxytol |
Primary outcome
Change in myocardial T2* magnetic resonance signal
Time frame: Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol
Change in T2*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.
1 secondary outcome
Change in systemic blood markers of inflammation
Time frame: Before, 1 day, 2 days, 4 days, 1 week and 1 month after administration of ferumoxytol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Derived from this study: PubMed 22875883Alam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Newby, FRCP, PhD principal investigator
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferumoxytol in people with Myocardial Infarction, run by University of Edinburgh at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in myocardial T2* magnetic resonance signal (time frame: Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01323296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.