IRon Nanoparticle Enhanced MRI in the Assessment of Myocardial infarctioN (IRNMAN)
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ClinicalTrials.gov Identifier: NCT01995799 |
Recruitment Status : Unknown
Verified November 2013 by University of Edinburgh.
Recruitment status was: Recruiting
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction Inflammation | Device: Ferumoxytol enhanced MRI | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | ASSESSMENT OF CELLULAR INFLAMMATION FOLLOWING ACUTE MYOCARDIAL INFARCTION Application Of Ultrasmall Superparamagnetic Particles Of Iron Oxide |
Study Start Date : | June 2013 |
Estimated Primary Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: USPIO timepoint 2-4 days
USPIO given 2-4 days post MI Ferumoxytol enhanced MRI
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Device: Ferumoxytol enhanced MRI
Ferumoxytol enhanced MRI scan |
Experimental: USPIO timepoint 5-7 days
USPIO given 5-7 days post MI Ferumoxytol enhanced MRI
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Device: Ferumoxytol enhanced MRI
Ferumoxytol enhanced MRI scan |
Experimental: USPIO tiempoint 11-21 days
USPIO given 11-21 days post MI Ferumoxytol enhanced MRI
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Device: Ferumoxytol enhanced MRI
Ferumoxytol enhanced MRI scan |
- R2* value [ Time Frame: MRI 24 hrs after USPIO infusion (regardless of time-point given) ]
Marker of USPIO uptake (and inflammation) in each cohort after myocardial infarction.
The USPIO infusion is given at different time-points for each cohort. However only the R2* value on the MRI 24 hours after infusion will constitute the primary end-point
- Serum Inflammatory markers [ Time Frame: 2-104 days post MI ]Correlation between blood and MRI inflammatory markers
- MRI parameters [ Time Frame: 2-104 days ]Ejection fraction change over time
- MRI parameters [ Time Frame: Baseline and 3 months ]Late enhancement volume change
- MRI parameter [ Time Frame: Baseline ]T2 oedema

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- >18 years
- Plasma troponin concentration >5 ng/mL; upper limit of normal 0.04 ng/mL)
- Acute myocardial infarction defined according to the Universal Definition of myocardial infarction
Exclusion Criteria:
- Critical (≥95%) left main stem coronary artery stenosis
- Continued symptoms of angina at rest or minimal exertion
- Past history of systemic iron overload or haemochromatosis
- Renal failure (estimated glomerular filtration rate <25 mL/min)
- Contraindication to magnetic resonance imaging
- Significant heart failure (Killip class ≥2)
- Known allergy to dextran- or iron-containing compounds

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): NCT01995799
Contact: Shirjel R Alam, MBChB | 0131 536 1000 ext ask for name | s.r.alam@sms.ed.ac.uk |
United Kingdom | |
Royal Infirmary of Edinburgh | Recruiting |
Edinburgh, Lothian, United Kingdom, EH16 4SA | |
Clinical Research Imaging Centre | Recruiting |
Edinburgh, Lothian, United Kingdom, EH16 4TJ | |
Contact: Semple scott.semple@ed.ac.uk |
Study Director: | Shirjel R Alam, MBChB | University of Edinburgh |
Responsible Party: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT01995799 |
Other Study ID Numbers: |
2013/R/CAR/04 |
First Posted: | November 27, 2013 Key Record Dates |
Last Update Posted: | November 27, 2013 |
Last Verified: | November 2013 |
Myocardial Infarction (and related inflammation) |
Myocardial Infarction Inflammation Infarction Pathologic Processes Ischemia Necrosis Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases Ferrosoferric Oxide Hematinics Parenteral Nutrition Solutions Pharmaceutical Solutions |