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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Tomas Kovarnik, General University Hospital, Prague.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01773512
First Posted: January 23, 2013
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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: 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.

Resource links provided by NLM:


Further study details as provided by Tomas Kovarnik, 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 ]
    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. ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Grant/Funding Number: Ministry of Health / Czech Republic Grant Agency )
First Submitted: January 16, 2013
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
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors