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

• ClinicalTrials.gov Identifier: NCT01773512
• Recruitment Status: Unknown
• Last Update Posted: January 23, 2013
• Sponsor: General University Hospital, Prague
• Collaborators: Ministry of Health, Czech Republic; Czech Ministry of Education; University of Iowa; Loyola University Chicago
• Information provided by (Responsible Party): Tomas Kovarnik, General University Hospital, Prague

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: Rosuvastatin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: June 2012
• Estimated Primary Completion Date: December 2014
• Estimated Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Rosuvastatin; All patients will be using rosuvastatin 40 mg	Drug: Rosuvastatin; All patients will be using rosuvastatin 40 mg

Outcome Measures

Primary Outcome Measures :

1. The prediction of plaque volume and plaque composition. [ Time Frame: 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 :

1. Prediction of changes in plaque volume and plaque composition [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

Loyola University Hospital; Active, not recruiting

Maywood, Illinois, United States, 60153

United States, Iowa

The University of Iowa; Active, not recruiting

Iowa City, Iowa, United States, 52242

Czech Republic

General University Hospital; Recruiting

Prague, Czech Republic, 12808

Contact: Tomas Kovarnik, MD, PhD +420224962687 tomas.kovarnik@vfn.cz

Contact: Jan Horak, MD, PhD +420224962605 jan.horak@vfn.cz

Principal Investigator: Tomas Kovarnik, MD, PhD

Sub-Investigator: Jan Horak, MD, PhD

Sub-Investigator: Hana Skalicka, MD, PhD

Sub-Investigator: Ales Kral, MD, PhD

Sub-Investigator: Ales Linhart, MD, professor

Sub-Investigator: Pavel Martasek, MD, professor

Sponsors and Collaborators

General University Hospital, Prague

Ministry of Health, Czech Republic

Czech Ministry of Education

University of Iowa

Loyola University Chicago

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Tomas Kovarnik, MD, PhD, General University Hospital, Prague
• ClinicalTrials.gov Identifier: NCT01773512
• Other Study ID Numbers: UK2012; IGA 2012 NT/13224 ( Other Grant/Funding Number: Ministry of Health / Czech Republic Grant Agency )
• First Posted: January 23, 2013
• Last Update Posted: January 23, 2013
• Last Verified: January 2013

Keywords provided by Tomas Kovarnik, General University Hospital, Prague:

Intravascular ultrasound; Virtual histology; Optical coherence tomography; Coronary atherosclerosis; Statins; Retinal imaging

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Arteriosclerosis; Rosuvastatin Calcium; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors