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Inflammatory Cell Trafficking After Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Edinburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01127113
First received: April 13, 2010
Last updated: May 19, 2010
Last verified: May 2010
History of Changes
  Purpose

Myocardial infarction (heart attack) is usually the consequence of rupture of a fatty 'plaque' in a heart artery. The presence of this fat and debris causes the propagation of a blood clot and blockage of the artery. The heart muscle normally supplied by the artery becomes deprived of oxygen and, if starved for long enough, this area of muscle dies. Much of the heart muscle damage is caused by overactivation of inflammatory cells. Whilst inflammation can be beneficial in healing processes, there is accumulating evidence that overactivation of inflammatory processes contributes to further muscle damage and cell death during myocardial infarction. We have recently developed a means of labelling human blood cells with 'nanoparticles' of iron oxide which can then safely be reinjected into the blood to allow the cells to be tracked and seen in the body using a conventional magnetic resonance scanner.

In the proposed study we aim to recruit patients with recent heart attacks to perform similar cell labelling and reinjection of labelled cells into the same volunteer's blood stream via the arm to track the fate of the blood cells over the course of days to months. We think that the labelled inflammatory cells will 'home' to the site of the heart attack and will be visible using magnetic resonance imaging (MRI) of the heart. We aim not only to highlight the role of inflammatory cells in myocardial infarction, but also propose that, if successful, this technique could be used in the future to assess the effects of antiinflammatory treatments currently being developed for the treatment of patients with heart attacks. The technique could also be extended to allow labelling of other cell types, including stem cells, to let us further understand how these cells may contribute to repair of damaged organs including the heart.


Condition Intervention
Myocardial Infarction
Inflammation
 Other: Infusion of investigational product
Other: Cardiac magnetic resonance imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Inflammatory Cell Labelling and Tracking With Magnetic Resonance Imaging After Myocardial Infarction

Resource links provided by NLM:

Drug Information available for: Ferumoxides
U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Change in cardiac MRI signal intensity from baseline after administration of labelled vs. unlabelled mononuclear cells. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of myocardial MRI signal intensity change from baseline with markers of systemic inflammation. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: January 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SPIO-labelled mononuclear cells Other: Infusion of investigational product
The investigational product will be delivered via intravenous infusion
Other Names:
  • The investigational product will be either:
  • 1) Unlabelled autologous mononuclear cells
  • 2) Endorem (Guerbet, Paris) contrast alone
  • 3) Autologous mononuclear cells labelled with Endorem
Other: Cardiac magnetic resonance imaging
Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after.
Placebo Comparator: Unlabelled mononuclear cells Other: Infusion of investigational product
The investigational product will be delivered via intravenous infusion
Other Names:
  • The investigational product will be either:
  • 1) Unlabelled autologous mononuclear cells
  • 2) Endorem (Guerbet, Paris) contrast alone
  • 3) Autologous mononuclear cells labelled with Endorem
Other: Cardiac magnetic resonance imaging
Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after.
Active Comparator: SPIO alone Other: Infusion of investigational product
The investigational product will be delivered via intravenous infusion
Other Names:
  • The investigational product will be either:
  • 1) Unlabelled autologous mononuclear cells
  • 2) Endorem (Guerbet, Paris) contrast alone
  • 3) Autologous mononuclear cells labelled with Endorem
Other: Cardiac magnetic resonance imaging
Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after.

  Eligibility

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

Inclusion Criteria:

  • Presentation with acute ST segment elevation myocardial infarction:

    • 1 mm ST elevation in at least two contiguous limb leads, or
    • 2 mm ST elevation in at least two contiguous praecordial leads, or new onset bundle branch block
  • Successful treatment with primary percutaneous coronary intervention Restoration of TIMI grade 3 flow in infarct-related artery
  • Troponin I ≥10 IU/mL at 12 hours after the onset of chest pain
  • Age 18 - 80 years

Exclusion Criteria:

  • Left main stem or severe multi-vessel coronary artery disease
  • Continued symptoms of angina at rest or minimal exertion
  • Atrial fibrillation
  • Symptomatic heart failure; Killip Class ≥2.
  • Hepatic or renal failure (estimated glomerular filtration rate <25 mL/min)
  • Terminal illness or malignancy
  • Anaemia
  • Contraindication to magnetic resonance imaging
  • Hepatitis B, hepatitis C, HTLV, HIV or syphilis infection
  • Patients at risk of allergy to protamine (fish allergy, infertile men, previous vasectomy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127113

Contacts
Contact: Ninian N Lang, MB ChB, PhD 00441315361000 ninianlang@gmail.com
Contact: Michelle Williams, BSc, MB ChB 00441315361000 michelle.williams@ed.ac.uk

Locations
United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4SU
Contact: Ninian Lang, MB ChB, PhD     0044131536000     ninianlang@gmail.com    
Contact: Michelle Williams, BSc, MB ChB     00441315361000     michelle.williams@ed.ac.uk    
Sub-Investigator: Ninian N Lang, MB ChB, PhD            
Sub-Investigator: Jennifer Richards, MB ChB            
Sub-Investigator: Michelle Williams, MB ChB, MRCP            
Sub-Investigator: Scott Semple, PhD            
Sub-Investigator: Renzo Pessotto, MD            
Sub-Investigator: Marc Turner, MB ChB, PhD            
Sub-Investigator: Huw Roddie, MB ChB, PhD            
Sub-Investigator: Graham McKillop, MB ChB            
Sub-Investigator: Katie Shaw, PhD            
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
Investigators
Principal Investigator: David E Newby, MD, PhD University of Edinburgh
  More Information

No publications provided

Responsible Party: Marise Bucukoglu, University of Edinburgh
ClinicalTrials.gov Identifier: NCT01127113     History of Changes
Other Study ID Numbers: EDO001
Study First Received: April 13, 2010
Last Updated: May 19, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Myocardial infarction
Magnetic resonance imaging
Nanoparticles
Mononuclear cells
Cell tracking

Additional relevant MeSH terms:
Infarction
Inflammation
Myocardial Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013