Clinical trial NCT01773512: The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Intravascular ultrasound
Virtual histology
Optical coherence tomography
Coronary atherosclerosis
Statins
Retinal imaging
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Czech Republic
name: Czech Ministry of Education
name: University of Iowa
name: Loyola University Chicago
First posted: 2013-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The prediction of plaque volume and plaque composition.
timeFrame: The patients will be followed in the study for one year
Secondary outcomes:
measure: Prediction of changes in plaque volume and plaque composition
timeFrame: The patients will be followed in the study for one year.
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Hospital
state: Illinois
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Prague
country: Czech Republic
facility: General University Hospital
Study officials:
References:
citation: Kovarnik T, Kral A, Skalicka H, Mintz GS, Kralik L, Chval M, Horak J, Skalicka L, Sonka M, Wahle A, Downe RW, Uhrova J, Benakova H, Cernohousova L, Martasek P, Belohlavek J, Aschermann M, Linhart A. The prediction of coronary artery disease based on non-invasive examinations and heme oxygenase 1 polymorphism versus virtual histology. J Invasive Cardiol. 2013 Jan;25(1):32-7.
citation: Sonka M, Downe RW, Garvin JW, Lopez J, Kovarnik T, Wahle A. IVUS-based assessment of 3D morphology and virtual histology: prediction of atherosclerotic plaque status and changes. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:6647-50. doi: 10.1109/IEMBS.2011.6091639.
citation: Kovarnik T, Chen Z, Mintz GS, Wahle A, Bayerova K, Kral A, Chval M, Kopriva K, Lopez J, Sonka M, Linhart A. Plaque volume and plaque risk profile in diabetic vs. non-diabetic patients undergoing lipid-lowering therapy: a study based on 3D intravascular ultrasound and virtual histology. Cardiovasc Diabetol. 2017 Dec 7;16(1):156. doi: 10.1186/s12933-017-0637-0.