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

Coronary Artery Disease Clinical Trial

— PREDICT  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01773512
• Other study ID #: UK2012
• Secondary ID: IGA 2012 NT/1322
• Status: Recruiting
• Phase: Phase 4
• First received: January 16, 2013
• Last updated: January 18, 2013
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: January 2013
• Source: General University Hospital, Prague
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Rosuvastatin
All patients will be using rosuvastatin 40 mg

Locations

Country	Name	City	State
Czech Republic	General University Hospital	Prague
United States	The University of Iowa	Iowa City	Iowa
United States	Loyola University Hospital	Maywood	Illinois

Sponsors (5)

Lead Sponsor	Collaborator
General University Hospital, Prague	Czech Ministry of Education, Loyola University Chicago, Ministry of Health, Czech Republic, University of Iowa

Countries where clinical trial is conducted

United States,  Czech Republic, 

References & Publications (2)

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. — View 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. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:6647-50. doi: 10.1109/IEMBS.2011.6091639. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prediction of plaque volume and plaque composition.	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.	The patients will be followed in the study for one year	No
Secondary	Prediction of changes in plaque volume and plaque composition	Prediction of changes in plaque composition and plaque volume during lipid lowering therapy based on changes of non-invasive examination.	The patients will be followed in the study for one year.	No