NCT01995799

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

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

May 24, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

June 19, 2013

Last Update Submit

May 8, 2024

Conditions

Myocardial InfarctionInflammation

Keywords

Myocardial Infarction (and related inflammation)

Outcome Measures

Primary Outcomes (1)

  • R2* value

    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

    MRI 24 hrs after USPIO infusion (regardless of time-point given)

Secondary Outcomes (1)

  • Serum Inflammatory markers

    2-104 days post MI

Other Outcomes (3)

  • MRI parameters

    2-104 days

  • MRI parameters

    Baseline and 3 months

  • MRI parameter

    Baseline

Study Arms (3)

USPIO timepoint 2-4 days

EXPERIMENTAL

USPIO given 2-4 days post MI Ferumoxytol enhanced MRI

Device: Ferumoxytol enhanced MRI

USPIO timepoint 5-7 days

EXPERIMENTAL

USPIO given 5-7 days post MI Ferumoxytol enhanced MRI

Device: Ferumoxytol enhanced MRI

USPIO tiempoint 11-21 days

EXPERIMENTAL

USPIO given 11-21 days post MI Ferumoxytol enhanced MRI

Device: Ferumoxytol enhanced MRI

Interventions

Ferumoxytol enhanced MRIDEVICE

Ferumoxytol enhanced MRI scan

USPIO tiempoint 11-21 daysUSPIO timepoint 2-4 daysUSPIO timepoint 5-7 days

Eligibility Criteria

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

You may qualify if:

  • \>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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Clinical Research Imaging Centre

Edinburgh, Lothian, EH16 4TJ, United Kingdom

Location

MeSH Terms

Conditions

Myocardial InfarctionInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Shirjel R Alam, MBChB

    University of Edinburgh

    STUDY DIRECTOR

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

June 19, 2013

First Posted

November 27, 2013

Study Start

May 24, 2013

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations

GB(2)