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Inflammatory Cell Trafficking After Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT01127113
Recruitment Status : Suspended
First Posted : May 20, 2010
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh

April 13, 2010
May 20, 2010
December 4, 2014
January 2010
November 2015   (Final data collection date for primary outcome measure)
Change in cardiac MRI signal intensity from baseline after administration of labelled vs. unlabelled mononuclear cells. [ Time Frame: 90 days ]
Same as current
Complete list of historical versions of study NCT01127113 on ClinicalTrials.gov Archive Site
Correlation of myocardial MRI signal intensity change from baseline with markers of systemic inflammation. [ Time Frame: 90 days ]
Same as current
Not Provided
Not Provided
 
Inflammatory Cell Trafficking After Myocardial Infarction
Inflammatory Cell Labelling and Tracking With Magnetic Resonance Imaging After Myocardial Infarction

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
  • Myocardial Infarction
  • Inflammation
  • 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-labelled mononuclear cells
    Interventions:
    • Other: Infusion of investigational product
    • Other: Cardiac magnetic resonance imaging
  • Placebo Comparator: Unlabelled mononuclear cells
    Interventions:
    • Other: Infusion of investigational product
    • Other: Cardiac magnetic resonance imaging
  • Active Comparator: SPIO alone
    Interventions:
    • Other: Infusion of investigational product
    • Other: Cardiac magnetic resonance imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
66
Same as current
March 2016
November 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01127113
EDO001
No
Not Provided
Not Provided
University of Edinburgh
University of Edinburgh
British Heart Foundation
Principal Investigator: David E Newby, MD, PhD University of Edinburgh
University of Edinburgh
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP