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

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.

• 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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Rosuvastatin

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czech Republic
  • Prague, Czech Republic, 12808
    • Recruiting
    • General University Hospital
    • Contact: Tomas Kovarnik, MD, PhD; Phone Number: +420224962687; Email: tomas.kovarnik@vfn.cz
    • Contact: Jan Horak, MD, PhD; Phone Number: +420224962605; Email: 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
• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Active, not recruiting
      • Loyola University Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Active, not recruiting
      • The University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rosuvastatin; All patients will be using rosuvastatin 40 mg	Drug: Rosuvastatin; All patients will be using rosuvastatin 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: General University Hospital, Prague
• Collaborators: University of Iowa; Loyola University Chicago; Ministry of Health, Czech Republic; Czech Ministry of Education

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (ESTIMATE): January 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 18, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Statins; Intravascular ultrasound; Retinal imaging; Coronary atherosclerosis; Virtual histology
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: UK2012; IGA 2012 NT/13224 (OTHER_GRANT: Ministry of Health / Czech Republic Grant Agency)