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临床试验/NCT00465868
NCT00465868已完成不适用

Magnetic Resonance Imaging, Myocardial Infarction and Development of Heart Failure.

Helse Stavanger HF1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2004年12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
44
试验地点
1

研究概览

简要总结

KoMPiS is a contrast aided cardiac magnetic resonance study of microvascular obstruction and left ventricular remodelling following acute revascularised anterior myocardial infarction. The study will monitor the included patients for 12 months following the acute myocardial infarct and collect data from MR scans and blood samples. The study is designed to demonstrate that obstruction of blood flow in the peripheral (small) vessels of the cardiac muscle is an important factor in the post-MI development of left ventricle dysfunction that occurs in many patients, despite of a successful re-opening of the occluded coronary artery that caused the MI.

详细描述

Introduction. Cardiovascular disease is responsible for 30 % of worldwide mortality, accounting for approximately 15 million deaths per year. Improvement in medical treatment strategies during the last decades has produced a tremendous decrease in mortality in connection with acute myocardial infarction (AMI). Since the 1960's, short-term mortality (30 days) has decreased from approximately 30 % to the current mortality rate of 6,5%. The success of modern treatment of AMI has, however, led to an increasing number of patients surviving AMI, thus creating a growing group of high-risk patients that need further treatment and care. The development of heart failure and the risk of recurrent ischemia and reinfarction are the two main threats to this population. To further improve the treatment and outcomes in this high risk population, early risk stratification based on a thorough understanding of the operating mechanisms behind the transition from acute infarction to heart failure is necessary.

AMI, reperfusion and microvascular obstruction. Reperfusion therapy has been one of the major successes in the treatment of AMI, and there are numerous studies to support the idea of opening occluded coronary arteries, especially in the context of an AMI. However, even in the presence of a patent infarct related artery, there may still be inadequate reperfusion at the tissue level. This phenomenon, known as no-reflow, may preclude optimal reperfusion because of microvascular obstruction. It is estimated that microvascular obstruction occurs in 30-40% of all revascularised patients in spite of a patent artery; the exact underlying pathophysiological mechanisms are partially unknown. Microvascular obstruction may possibly be due to sequestration of neutrophils in the microvasculature that subsequently lead to microvascular occlusion by erythrocytes, leucocytes and cellular debris. It remains unclear whether the stimulus for the development of microvascular obstruction originates during coronary occlusion exclusively or if reperfusion plays an active role in progression of the phenomenon.

Microvascular obstruction and heart failure. The presence of microvascular obstruction following AMI, predicts unfavourable postinfarction prognosis and development of left ventricular dysfunction and left ventricular remodelling. Left ventricular remodelling is associated with development of heart failure and is directly related to the magnitude of microvascular obstruction early after experimental and clinical AMI1, as well as 6 months after the acute event. The mechanisms by which microvascular obstruction induces ventricular remodelling remain unknown. Possibilities include the potentiation of wall thinning and infarct expansion early after infarction, as well as potential impairment of infarct healing, given the association between presence of microvascular obstruction and greater transmural scar formation 6 months after AMI.

Assessment of microvascular obstruction. Until recently, microvascular obstruction could only be assessed by methods such as radioactive micro-spheres and other histopathological techniques, that only could be performed at the terminal phase of an experimental study, and not clinically. However, recent advances in the field of non-invasive cardiac imaging have enabled the serial assessment of this phenomenon by cardiac magnetic resonance imaging (CMR), thereby facilitating a much greater understanding of its pathophysiological and prognostic significance.

Assessment of left ventricular remodelling by CMR. The pathologic changes associated with the development of heart failure include changes in geometry and function, myocytes and extracellular matrix. Assessment of left ventricular remodelling includes estimation of left ventricular size and shape, left ventricular mass and a functional assessment including an estimation of ejection fraction.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Men or women > 18 years of age, non-child bearing potential
  • First time acute myocardial infarction, as determined by evidence of transmural ischemia in the ECG and a rise in cardiac-Troponin-T (TNT) > 0,1 (μg/l), followed by
  • A successful acute PCI of a single vessel disease with a proximal/mid left anterior descent artery (LAD), circumflex artery (RCX) or right coronary artery (RCA) lesion (the index PCI).

排除标准

  • Extensive cardiopulmonary resuscitation.
  • Haemodynamically unstable patients, unable to leave the coronary care unit for the CMR examination.
  • Use of fibrinolytics immediately prior to the index PCI.
  • Significant primary valve disease,
  • Autoimmune disease causing an increase in collagen turnover
  • Active cancer disease
  • Need for immunosuppressive treatment,
  • Significantly reduced liver function
  • Contraindications for performing a cardiac MRI-scan (claustrophobia, and implanted ferromagnetic devices, known allergic reactions to Omniscan™).
  • Inability to understand the consent form or cooperate during the 1 year follow up.
  • Comorbidity with poor prognosis.

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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