Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT02350959
Brief Summary:
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.
Detailed Description:
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:
NCT02350959
Study Brief:
Protocol Section:
NCT02350959