NCT02350959

Adverse Plaque Characteristics in CCTA and TVC Imaging

Evaluation of Adverse Plaque Characteristics in Coronary Computed Tomography Angiography Using Combined Near Infrared Spectroscopy With Intravascular Ultrasound [CITRUS Study]

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Health Insurance Service Ilsan Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plaque

Interventions

Type	Name	Description
DRUG	Atorvastatin	in moderate dosea statin group, atorvastatin 10mg will be used and maintained until follow up angiography
DRUG	Atorvastatin	in high dose statin group, atorvastatin 40mg will be used and maintained until follow up angiography

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2017-01-01
• First posted: 2015-01-30
• Last updated: 2015-10-07

Locations

1 site across 1 country: South Korea