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临床试验/NCT01127113
NCT01127113撤回不适用

Inflammatory Cell Labelling and Tracking With Magnetic Resonance Imaging After Myocardial Infarction

University of Edinburgh2 个研究点 分布在 1 个国家开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in cardiac MRI signal intensity from baseline after administration of labelled vs. unlabelled mononuclear cells.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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 ≥
  • Hepatic or renal failure (estimated glomerular filtration rate <25 mL/min)
  • Terminal illness or malignancy
  • 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)

结局指标

主要结局

Change in cardiac MRI signal intensity from baseline after administration of labelled vs. unlabelled mononuclear cells.

时间窗: 90 days

次要结局

  • Correlation of myocardial MRI signal intensity change from baseline with markers of systemic inflammation.(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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