Inflammatory Cell Trafficking After Myocardial Infarction

May 1, 2024 updated by: University of Edinburgh

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH16 4SU
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cardiac MRI signal intensity from baseline after administration of labelled vs. unlabelled mononuclear cells.
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of myocardial MRI signal intensity change from baseline with markers of systemic inflammation.
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

British Heart Foundation

Investigators

  • Principal Investigator: David E Newby, MD, PhD, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Estimated)

November 1, 2015

Study Completion (Estimated)

March 1, 2016

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimated)

May 20, 2010

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDO001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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