The present study is intended to assess the vulnerability of plaques seen on CCTA by means of TVC Imaging System and to make comparisons between plaques with adverse plaque characteristics and ones without adverse plaque characteristics in terms of plaque volume and lipid core contents.
This study is to be conducted in two phases - Phases 1 and 2. In Phase 1, the vulnerability of plaques seen on CCTA will be assessed with TVC Imaging System, and the plaque volume and lipid core contents of plaques with versus without adverse plaque characteristics will be compared. For the purpose of this study, the study of this phase will be a cross-sectional study in which the shapes of vulnerable plaques seen on CCTA will be compared to their vulnerability visualized by the TVC Imaging System. In Phase 2, the patients with multi-vessel (polyvascular) disease of those participating in Phase 1 will be included, and the study of this phase will be a longitudinal study in which serial TVC imaging will be performed for non-target vessels, and any differences in changes of plaque vulnerability when treated with moderate-dose versus high-dose statin will be comparatively analyzed. The purpose of the present study is to determine whether there are any significant differences in changes of plaque volume and stability when treated with high-dose versus moderate-dose statin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
in moderate dosea statin group, atorvastatin 10mg will be used and maintained until follow up angiography
in high dose statin group, atorvastatin 40mg will be used and maintained until follow up angiography
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGthe change of max LCBI(4mm): Lipid core burden index in 4 mm
The primary endpoint for this study is the change of max LCBI(4mm) between initial and follow up angiography in non-target vessel
Time frame: 1 year
Correlation between vulnerable plaque on CT and max LCBI(4mm)
The other primary endpoint of this study is Vessel level correlation of vulnerable plaque on CT and LCBI(4mm)
Time frame: maximum duration of 3 months between CT and NIRS
the change of presence of maxLCBI(4mm) > 500
vessel level comparison between initial and follow up angiography in non-target vessel
Time frame: 1 year
the change of CT plaque vulnerability
the change of Positive remodeling, Low attenuation plaque, Spotty calcification
Time frame: 2years
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