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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT01773512
• Lead Sponsor: General University Hospital, Prague

Brief Summary

* 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.

Detailed Description

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 Timeline

• Study Start: 2012-06
• Status Verified: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-18
• Last Update Submitted: 2013-01-18
• Study First Posted: 2013-01-23
• Last Update Posted: 2013-01-23
• Primary Completion: 2014-12
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	All patients will be using rosuvastatin 40 mg

Primary Outcome Measures

Name	Time	Method
The prediction of plaque volume and plaque composition.	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.

Secondary Outcome Measures

Name	Time	Method
Prediction of changes in plaque volume and plaque composition	The patients will be followed in the study for one year.	Prediction of changes in plaque composition and plaque volume during lipid lowering therapy based on changes of non-invasive examination.

Trial Locations

Locations (3)

General University Hospital; 🇨🇿 Prague, Czech Republic

The University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Loyola University Hospital; 🇺🇸 Maywood, Illinois, United States