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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPIO-labelled mononuclear cells | Active Comparator |
| |
| Unlabelled mononuclear cells | Placebo Comparator |
| |
| SPIO alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion of investigational product | Other | The investigational product will be delivered via intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac MRI signal intensity from baseline after administration of labelled vs. unlabelled mononuclear cells. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of myocardial MRI signal intensity change from baseline with markers of systemic inflammation. | 90 days |
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Inclusion Criteria:
Presentation with acute ST segment elevation myocardial infarction:
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:
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| Name | Affiliation | Role |
|---|---|---|
| David E Newby, MD, PhD | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | Midlothian | EH16 4SU | United Kingdom |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C065507 | ferumoxides |
| D003287 | Contrast Media |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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|
| Cardiac magnetic resonance imaging | Other | Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after. |
|
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |