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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by General University Hospital, Prague
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01773512
First received: January 16, 2013
Last updated: January 18, 2013
Last verified: January 2013
  Purpose
  • 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 Intervention Phase
Coronary Artery Disease
Drug: Rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by General University Hospital, Prague:

Primary Outcome Measures:
  • The prediction of plaque volume and plaque composition. [ Time Frame: The patients will be followed in the study for one year ] [ Designated as safety issue: No ]
    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:
  • Prediction of changes in plaque volume and plaque composition [ Time Frame: The patients will be followed in the study for one year. ] [ Designated as safety issue: No ]
    Prediction of changes in plaque composition and plaque volume during lipid lowering therapy based on changes of non-invasive examination.


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin
All patients will be using rosuvastatin 40 mg
Drug: Rosuvastatin
All patients will be using rosuvastatin 40 mg

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773512

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:
Responsible Party: Tomas Kovarnik, MD, PhD, General University Hospital, Prague
ClinicalTrials.gov Identifier: NCT01773512     History of Changes
Other Study ID Numbers: UK2012, IGA 2012 NT/13224
Study First Received: January 16, 2013
Last Updated: January 18, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by General University Hospital, Prague:
Intravascular ultrasound
Virtual histology
Optical coherence tomography
Coronary atherosclerosis
Statins
Retinal imaging

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014