Coronary Artery DiseasePhase 4PREDICTNCT01773512
The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques
A Phase 4 study testing Rosuvastatin in people with Coronary Artery Disease, run by General University Hospital, Prague at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2012to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable angina pectoris
Who cannot join
- 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
Show all 9Show fewer
- acute coronary syndrome in last 6 weeks
- coronary anatomy unsuitable for intravascular ultrasound
- active cancer
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
- Active, not recruiting
The University of Iowa
Iowa City, Iowa, 52242
- Active, not recruiting
Loyola University Hospital
Maywood, Illinois, 60153
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital
Prague, 12808
Tomas Kovarnik, MD, PhD, +420224962687, tomas.kovarnik@vfn.cz
Jan Horak, MD, PhD, +420224962605, jan.horak@vfn.cz
About this study
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.
- 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Rosuvastatin
- Keywords
- Intravascular ultrasound, Virtual histology, Optical coherence tomography, Coronary atherosclerosis, Statins, Retinal imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
All patients will be using rosuvastatin 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | All patients will be using rosuvastatin 40 mg Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The patients will be followed in the study for one year
Secondary outcomes (1)
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.
Measured: The patients will be followed in the study for one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Czech Republic, Czech Ministry of Education, University of Iowa, Loyola University Chicago
- Responsible party
- Principal investigator, Tomas Kovarnik, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773512
- Sponsor's protocol ID
- UK2012
- Other IDs
- IGA 2012 NT/13224
- Acronym
- PREDICT
- Status last verified
- Jan 2013
- First submitted
- 16 Jan 2013
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23293173Sonka 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.
PubMed 22255863Kovarnik 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.
PubMed 29212544
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01773512
- Acronym / sponsor ID
- PREDICT / UK2012
- Conditions
- Coronary Artery Disease
- Keywords
- Intravascular ultrasound, Virtual histology, Optical coherence tomography, Coronary atherosclerosis, Statins, Retinal imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Collaborators
- Ministry of Health, Czech Republic, Czech Ministry of Education, University of Iowa, Loyola University Chicago
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: RosuvastatinAll patients will be using rosuvastatin 40 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable angina pectoris
Key exclusion criteria (9 listed)
- age less than 18 or more than 80
- renal insufficiency
- liver insufficiency
- pregnancy or , child potential without contraception
- intolerance of statins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAll patients will be using rosuvastatin 40 mg | Drug | Rosuvastatin |
Primary outcome
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.
1 secondary outcome
Prediction of changes in plaque volume and plaque composition
Time frame: The patients will be followed in the study for one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Background: PubMed 23293173Kovarnik 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.
- Background: PubMed 22255863Sonka 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.
- Derived from this study: PubMed 29212544Kovarnik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Coronary Artery Disease, run by General University Hospital, Prague at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prediction of plaque volume and plaque composition. (time frame: The patients will be followed in the study for one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01773512, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.