NCT01995799: IRNMAN

IRon Nanoparticle Enhanced MRI in the Assessment of Myocardial infarctioN

Completed Phase 2 Last updated 10 May 2024

What this trial tests

Phase 2 trial testing Ferumoxytol enhanced MRI in Myocardial Infarction in 30 participants. Completed in 30 June 2015.

Timeline

24 May 2013

Primary endpoint
30 June 2015

30 June 2015

Quick facts

Lead sponsor	University of Edinburgh
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	30
Start date	24 May 2013
Primary completion	30 June 2015
Estimated completion	30 June 2015
Sites	2 locations across United Kingdom

Drugs / interventions tested

• Ferumoxytol enhanced MRI

Conditions studied

• Myocardial Infarction — all drugs for Myocardial Infarction →
• Inflammation — all drugs for Inflammation →

Sponsor

University of Edinburgh

Who can join

18 and older, any sex, with Myocardial Infarction or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ferumoxytol is an example of a 'smart' magnetic resonance contrast agent that consists of ultrasmall superparamagnetic particles of iron oxide (USPIOs) and is avidly taken up by macrophages. Through a previous work, the investigators have established that USPIOs can identify inflammation in the wall of abdominal aortic aneurysms and that this is associated with a three-fold increase in the rate of aneurysm growth. The utility of ferumoxytol for imaging cardiovascular inflammation in other areas of the body has yet to be established but Dr Alam has established uptake of USPIOs in the penumbra and infarct zone of the myocardium in patients with a recent myocardial infarction. The investigators wish to assess USPIO uptake in patients with recent acute myocardial infarction and identify the time course and determinants of cellular tissue inflammation. This will be the first clinical study to examine the ability of USPIOs to image myocardial inflammation following acute myocardial infarction.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Review of Clinical Translation of Inorganic Nanoparticles.
   Anselmo AC, Mitragotri S. · · 2015 · cited 263× · PMID 25956384 · DOI 10.1208/s12248-015-9780-2
2. Clinically Approved Nanoparticle Imaging Agents.
   Thakor AS, Jokerst JV, Ghanouni P, Campbell JL, et al · · 2016 · cited 151× · PMID 27738007 · DOI 10.2967/jnumed.116.181362
3. Engineering Iron Oxide Nanoparticles for Clinical Settings.
   Cortajarena AL, Ortega D, Ocampo SM, Gonzalez-García A, et al · · 2014 · cited 78× · PMID 30023013 · DOI 10.5772/58841
4. Nanopharmaceuticals (part 2): products in the pipeline.
   Weissig V, Guzman-Villanueva D. · · 2015 · cited 53× · PMID 25709446 · DOI 10.2147/ijn.s65526
5. Nanoparticles in the diagnosis and treatment of vascular aging and related diseases.
   Xu H, Li S, Liu YS. · · 2022 · cited 52× · PMID 35817770 · DOI 10.1038/s41392-022-01082-z
6. Promising Directions in Atherosclerosis Treatment Based on Epigenetic Regulation Using MicroRNAs and Long Noncoding RNAs.
   Skuratovskaia D, Vulf M, Komar A, Kirienkova E, et al · · 2019 · cited 42× · PMID 31212708 · DOI 10.3390/biom9060226
7. Emerging trends in the nanomedicine applications of functionalized magnetic nanoparticles as novel therapies for acute and chronic diseases.
   Dash S, Das T, Patel P, Panda PK, et al · · 2022 · cited 29× · PMID 36045375 · DOI 10.1186/s12951-022-01595-3
8. Nanocarriers for targeted drug delivery in the vascular system: focus on endothelium.
   Cong X, Zhang Z, Li H, Yang YG, et al · · 2024 · cited 28× · PMID 39396002 · DOI 10.1186/s12951-024-02892-9