Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Change in myocardial T2* magnetic resonance signal
研究概览
简要总结
The investigators wish to examine whether a novel 'nanoparticle' of iron oxide, administered intravenously allows an area of heart muscle damage after heart attack to be visualised using a magnetic resonance scanner.
详细描述
Using ferumoxtran (Feraheme) as a USPIO contrast agent for magnetic resonance imaging at 3 Tesla, we aim to conduct the first clinical study to examine the utility of this novel contrast agent to image myocardial inflammation after myocardial infarction.
We will test the following hypotheses in patients who have suffered recent acute myocardial infarction.
- Intravenous injection of ferumoxytol accumulates at the site of myocardial infarction and this can be visualised by magnetic resonance imaging.
- The spatial extent of the MRI signal change evoked by ferumoxytol in the myocardium is proportional to the volume of infarcted myocardium (as assessed by a gadolinium late-enhancement study).
- Myocardial MRI signal change evoked by ferumoxytol is positively correlated with blood markers of systemic inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •Presentation with myocardial infarction (either 'ST-elevation' myocardial infarction or 'non-ST-elevation' myocardial infarction
- •Troponin I ≥ 10 IU/mL at 12 hours after the onset of chest pain
- •Age 18 - 80 years inclusive
排除标准
- •Known critical (≥95%) left main stem coronary artery disease
- •Continued symptoms of angina at rest or minimal exertion
- •Atrial fibrillation
- •Symptomatic heart failure; Killip Class ≥
- •Hepatic failure (Childs-Pugh grade B or C) or renal failure (estimated glomerular filtration rate <25 mL/min)
- •Contraindication to magnetic resonance imaging
- •Past history of systemic iron overload/haemochromatosis
- •Patients with known allergy to dextran- or iron-containing compounds
结局指标
主要结局
Change in myocardial T2* magnetic resonance signal
时间窗: Before, 1 day, 2 days, 4 days, 1 week and 1 month post ferumoxytol
Change in T2\*weighted myocardial signal as assessed by magnetic resonance imaging before and after ferumoxytol administration.
次要结局
- Change in systemic blood markers of inflammation(Before, 1 day, 2 days, 4 days, 1 week and 1 month after administration of ferumoxytol)