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临床试验/NCT00987259
NCT00987259已完成不适用

Determination of the Time Course of Myocardial Oedema Post Myocardial Infarction Treated With Primary Angioplasty Using Cardiac Magnetic Resonance Imaging

Barts & The London NHS Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Extent and time course of myocardial oedema over the first 10 days post MI

研究概览

简要总结

Despite recent improvements in treatment, myocardial infarction (heart attack) is still a leading cause of illness and death in the UK. Following the acute event, it is difficult to predict which patients are at risk of further problems, such as heart failure and is therefore difficult to know which patients need more aggressive/intensive treatment and monitoring.

There needs to be a test which is safe, reliable and reproducible that can be used shortly after a heart attack to both predict future cardiac events and to allow the efficacy of new treatments to be assessed.

Myocardial oedema (swelling of the heart muscle) has been demonstrated using Cardiac Magnetic Resonance (CMR), to occur following a heart attack and has been suggested as a marker for future cardiac events. The optimum time to perform this scan, the method of data analysis and it's effectiveness as a predictor of future cardiac events has not been adequately assessed.

This trial will assess the amount and natural time-course of oedema in the first 10 days following a heart attack. It will also correlate the amount of oedema with the size of scar (damaged heart muscle) and left ventricular ejection fraction (heart function) at 3 months to assess if it is a predictive marker.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Patients presenting to the London Chest Hospital with acute ST elevation myocardial infarction and treated with primary angioplasty and stent implantation within 12 hours of symptom onset
  • Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2)
  • At the time of inclusion, the patient no longer requires intravenous catecholamines or mechanical hemodynamic support (aortic balloon pump)
  • Serum troponin >1ng/ml 12 hours after onset of pain
  • The patient is able to give written informed consent
  • The patient must be able to understand and communicate in English

排除标准

  • Known cardiomyopathy
  • Previous documented myocardial infarction
  • Previous percutaneous coronary intervention or coronary artery bypass surgery
  • Significant renal dysfunction (EGFR<30)
  • Systemic steroid therapy
  • Current non steroidal anti-inflammatory drug use
  • Chronic inflammatory disease
  • Neoplastic disease without documented remission within the past 5 years
  • Reduced mental capacity leading to inability to obtain informed consent
  • Participation in another clinical trial within the last 30 days

结局指标

主要结局

Extent and time course of myocardial oedema over the first 10 days post MI

时间窗: Days 1, 3 and 10 post MI

次要结局

  • Left ventricular ejection fraction and left ventricular scar size at 3 months(90 days post MI)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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