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Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01323296
First received: March 24, 2011
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Myocardial Infarction
Other: Ferumoxytol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Change in myocardial T2* magnetic resonance signal [ Time Frame: Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol ] [ Designated as safety issue: No ]
    Change in T2*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change in systemic (blood) markers of inflammation over time after myocardial infarction and correlation with T2*weighted MR signal after administration of ferumoxytol.


Estimated Enrollment: 18
Study Start Date: November 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ferumoxytol
Patients will be administered intravenous ferumoxytol 1 - 3 days following myocardial infarction after baseline cardiac magnetic resonance scanning.
Other: Ferumoxytol
One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)
Other Name: Feraheme; Advanced Magnetics, Inc., Cambridge, MA
No Intervention: Control
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.

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.

  1. Intravenous injection of ferumoxytol accumulates at the site of myocardial infarction and this can be visualised by magnetic resonance imaging.
  2. 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).
  3. Myocardial MRI signal change evoked by ferumoxytol is positively correlated with blood markers of systemic inflammation.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323296

Contacts
Contact: Ninian N Lang, PhD, MRCP 00441315361000 ninianlang@gmail.com

Locations
United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Contact: Ninian N Lang, PhD, MRCP    00441315361000    ninianlang@gmail.com   
Contact: Shirjel Alam, MRCP    00441315361000    shirjel@doctors.org.uk   
Principal Investigator: Ninian N Lang, PhD, MRCP         
Sub-Investigator: Shirjel Alam, MRCP         
Sub-Investigator: Michelle Williams, MRCP         
Sub-Investigator: Jennifer Richards, MRCS         
University of Edinburgh Recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4SU
Contact: Ninian Lang, PhD, MRCP    00441315361000    ninianlang@gmail.com   
Contact: Shirjel Alam, MRCP    00441315361000    shirjel@doctors.org.uk   
Principal Investigator: Ninian N Lang, PhD, MRCP         
Sub-Investigator: Shirjel Alam, MRCP         
Sub-Investigator: Jennifer Richards, MRCS         
Sub-Investigator: Scott K Semple, PhD         
Sponsors and Collaborators
University of Edinburgh
Investigators
Principal Investigator: David E Newby, FRCP, PhD University of Edinburgh
  More Information

No publications provided by University of Edinburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marise Bucukoglu, University of Edinburgh
ClinicalTrials.gov Identifier: NCT01323296     History of Changes
Other Study ID Numbers: 10/S1103/50 (REC REF)
Study First Received: March 24, 2011
Last Updated: March 24, 2011
Health Authority: United Kingdom: University of Edinburgh

Keywords provided by University of Edinburgh:
Myocardial infarction
Magnetic resonance
Nanoparticle
Iron
Inflammation

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Ferrosoferric Oxide
Hematinics
Hematologic Agents
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014