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临床试验/NCT01773512
NCT01773512Unknown4 期

The Prediction of Extent and Risk Profile of Coronary Atherosclerosis (Examined by Intravascular Ultrasound, Virtual Histology and Optical Coherence Tomography) and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques.

General University Hospital, Prague3 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
60
试验地点
3
主要终点
The prediction of plaque volume and plaque composition.

研究概览

简要总结

  • The prediction of extent and risk profile of coronary atherosclerosis based on clinical evaluation and non-invasive techniques.
  • Detailed analysis of plaque volume, plaque composition, risk plaque features and shear stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel reconstruction.
  • Prediction of changes in coronary arteries based on changes in non-invasive examinations.
  • Examination of WSS influence on atherosclerosis development and changes of WSS during lipid lowering therapy.

详细描述

The fundamental aim of this project is development of reliable algorithm for detection of extent and risk profile of coronary atherosclerosis based on non-invasive examinations (carotid ultrasound, examination of retinal vessel, diagnosis of endothelial dysfunction, pro-inflammatory markers including new markers of atherosclerosis and gene polymorphisms) with maximal effort on diagnosis of vulnerable plaques. The second part of the study is prediction of coronary atherosclerosis changes during high-dose lipid-lowering therapy (rosuvastatin 40 mg daily). Coronary artery impairment will be examined by up-to date technology using the fusion of angiography, intravascular ultrasound and virtual histology for 3D coronary artery reconstruction together with information about mechanical properties of arteries like a vessel shear stress. This algorithm for non-invasive assessment of coronary impairment and its changes during will be used for detection of high risk patients (in terms of acute coronary syndrome development) and of patients with low response to statin therapy. Further target is detailed assessment of atherosclerosis development and its changes during lipid-lowering therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • stable angina pectoris

排除标准

  • age less than 18 or more than 80
  • renal insufficiency
  • liver insufficiency
  • pregnancy or , child potential without contraception
  • intolerance of statins
  • rhabdomyolysis or other myopathy in patient´s history
  • acute coronary syndrome in last 6 weeks
  • coronary anatomy unsuitable for intravascular ultrasound
  • active cancer

研究组 & 干预措施

Rosuvastatin

Experimental

All patients will be using rosuvastatin 40 mg

干预措施: Rosuvastatin (Drug)

结局指标

主要结局

The prediction of plaque volume and plaque composition.

时间窗: The patients will be followed in the study for one year

The study is looking for non-invasive predictors of plaque volume and plaque composition. The non-invasive predictors include carotid ultrasound, polymorphism in gene for heme-oxygenase 1 and retinal imaging.

次要结局

  • Prediction of changes in plaque volume and plaque composition(The patients will be followed in the study for one year.)

研究者

发起方
General University Hospital, Prague
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomas Kovarnik

MD, PhD

General University Hospital, Prague

研究点 (3)

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