The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques (PREDICT)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Intravascular ultrasound, Virtual histology, Optical coherence tomography, Coronary atherosclerosis, Statins, Retinal imaging
Eligibility 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
Sites / Locations
- Loyola University Hospital
- The University of Iowa
- General University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rosuvastatin
Arm Description
All patients will be using rosuvastatin 40 mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01773512
First Posted
January 16, 2013
Last Updated
January 18, 2013
Sponsor
General University Hospital, Prague
Collaborators
Ministry of Health, Czech Republic, Czech Ministry of Education, University of Iowa, Loyola University Chicago
1. Study Identification
Unique Protocol Identification Number
NCT01773512
Brief Title
The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General University Hospital, Prague
Collaborators
Ministry of Health, Czech Republic, Czech Ministry of Education, University of Iowa, Loyola University Chicago
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Intravascular ultrasound, Virtual histology, Optical coherence tomography, Coronary atherosclerosis, Statins, Retinal imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
All patients will be using rosuvastatin 40 mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
All patients will be using rosuvastatin 40 mg
Primary Outcome Measure Information:
Title
The prediction of plaque volume and plaque composition.
Description
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.
Time Frame
The patients will be followed in the study for one year
Secondary Outcome Measure Information:
Title
Prediction of changes in plaque volume and plaque composition
Description
Prediction of changes in plaque composition and plaque volume during lipid lowering therapy based on changes of non-invasive examination.
Time Frame
The patients will be followed in the study for one year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Loyola University Hospital
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
General University Hospital
City
Prague
ZIP/Postal Code
12808
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomas Kovarnik, MD, PhD
Phone
+420224962687
Email
tomas.kovarnik@vfn.cz
First Name & Middle Initial & Last Name & Degree
Jan Horak, MD, PhD
Phone
+420224962605
Email
jan.horak@vfn.cz
First Name & Middle Initial & Last Name & Degree
Tomas Kovarnik, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jan Horak, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hana Skalicka, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ales Kral, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ales Linhart, MD, professor
First Name & Middle Initial & Last Name & Degree
Pavel Martasek, MD, professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
23293173
Citation
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.
Results Reference
background
PubMed Identifier
22255863
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. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:6647-50. doi: 10.1109/IEMBS.2011.6091639.
Results Reference
background
PubMed Identifier
29212544
Citation
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.
Results Reference
derived
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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
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