Trial | NCT01773512  Report issue

Title

The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques
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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
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.
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.
Study Started
Jun 30
2012
Primary Completion
Dec 31
2014
Anticipated
Study Completion
Jun 30
2015
Anticipated
Last Update
Jan 23
2013
Estimate

Drug Rosuvastatin

All patients will be using rosuvastatin 40 mg

Rosuvastatin Experimental

All patients will be using rosuvastatin 40 mg

Criteria 

Inclusion Criteria:

stable angina pectoris

Exclusion Criteria:

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
No Results Posted