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

General University Hospital, Prague

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01773512

UK2012

IGA 2012 NT/13224 (Other Grant/Funding Number)

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Rosuvastatin

Experimental group

Description:

All patients will be using rosuvastatin 40 mg

Treatment:

Drug: Rosuvastatin