Inflammatory Cell Trafficking After Myocardial Infarction

NCT ID: NCT01127113

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2016-03-31

Brief Summary

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.

Conditions

Myocardial Infarction; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

SPIO-labelled mononuclear cells

Group Type: ACTIVE_COMPARATOR

Infusion of investigational product

Intervention Type: OTHER

The investigational product will be delivered via intravenous infusion

Cardiac magnetic resonance imaging

Intervention Type: OTHER

Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after.

Unlabelled mononuclear cells

Group Type: PLACEBO_COMPARATOR

Infusion of investigational product

Intervention Type: OTHER

The investigational product will be delivered via intravenous infusion

Cardiac magnetic resonance imaging

Intervention Type: OTHER

Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after.

SPIO alone

Group Type: ACTIVE_COMPARATOR

Infusion of investigational product

Intervention Type: OTHER

The investigational product will be delivered via intravenous infusion

Cardiac magnetic resonance imaging

Intervention Type: OTHER

Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after.

Interventions

Infusion of investigational product

The investigational product will be delivered via intravenous infusion

Intervention Type: OTHER

Cardiac magnetic resonance imaging

Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after.

Intervention Type: OTHER

Other Intervention 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

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Heart Foundation

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David E Newby, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, United Kingdom

Countries

United Kingdom

Other Identifiers

EDO001

Identifier Type: -

Identifier Source: org_study_id