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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

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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01773512
Acronym
PREDICT
Enrollment
60
Registered
2013-01-23
Start date
2012-06-30
Completion date
2015-06-30
Last updated
2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Intravascular ultrasound, Virtual histology, Optical coherence tomography, Coronary atherosclerosis, Statins, Retinal imaging

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.

Interventions

DRUGRosuvastatin

All patients will be using rosuvastatin 40 mg

Sponsors

Ministry of Health, Czech Republic
CollaboratorOTHER_GOV
Czech Ministry of Education
CollaboratorOTHER_GOV
University of Iowa
CollaboratorOTHER
Loyola University Chicago
CollaboratorOTHER
General University Hospital, Prague
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The prediction of plaque volume and plaque composition.The patients will be followed in the study for one yearThe 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

MeasureTime frameDescription
Prediction of changes in plaque volume and plaque compositionThe 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.

Countries

Czechia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026