Evaluation of Adverse Plaque Characteristics in Coronary Computed Tomography Angiography Using Combined Near Infrared Spectroscopy With Intravascular Ultrasound [CITRUS Study]
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the change of max LCBI(4mm): Lipid core burden index in 4 mm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years of older
- •Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia
- •Patients with signed informed consent
- •Confirmed coronary artery disease in computed tomography
排除标准
- •The past history of coronary artery disease (e.g., myocardial infarction, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), etc.)
- •Less than 2-year life expectancy due to non-cardiac disease
- •If the subject cannot voluntarily agree in writing to participate in this study
- •If the subject is currently participating in any other study with another investigational drug or medical device
- •Allergic reaction to iodinated contrast media
- •Significant renal dysfunction (Serum creatinine > 1.5 mg/dl) 7 Heart rate ≥ 80 beats per minute even after treatment with a heart rate lowering medication which disable to take CCTA
- •Contraindications of either β blockers or nitroglycerin
- •The past history of complex congenital heart disease
- •Pregnant women or women with potential childbearing
- •Body mass index (BMI) exceeding 35
- •Irregular heartbeats which disable to take CCTA
- •Contraindications of statin due to hypersensitivity, past history of serious complication such as myopathy or increased liver enzyme more than 3 times of normal upper limit
研究组 & 干预措施
High dose statin
In high dose statin group, atorvastatin 40mg will be used
干预措施: Atorvastatin (Drug)
Moderate dose statin
in moderate dose statin group, atorvastatin 10mg will be used
干预措施: Atorvastatin (Drug)
结局指标
主要结局
the change of max LCBI(4mm): Lipid core burden index in 4 mm
时间窗: 1 year
The primary endpoint for this study is the change of max LCBI(4mm) between initial and follow up angiography in non-target vessel
Correlation between vulnerable plaque on CT and max LCBI(4mm)
时间窗: maximum duration of 3 months between CT and NIRS
The other primary endpoint of this study is Vessel level correlation of vulnerable plaque on CT and LCBI(4mm)
次要结局
- the change of presence of maxLCBI(4mm) > 500(1 year)
- the change of CT plaque vulnerability(2years)
研究者
Sanghoon Shin
Director, Clinical Research
National Health Insurance Service Ilsan Hospital