Virtual Histology (VH)-Intravascular Ultrasound (IVUS) Tissue Characteristics Analysis of the Intermediate Coronary Artery Stenosis Lesion Predicting Physiologic Myocardial Ischemia by Myocardial Fraction Flow Reserve (FFR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Differences VH-IVUS plaque composition between different FFR groups
研究概览
简要总结
Recent clinical trials demonstrated that virtual histology-intravascular ultrasound (VH-IVUS) is a useful test predicting clinical outcomes of the coronary artery disease (CAD). Thin cap fibroatheroma (VH-TCFA) was proposed a predictor of cardiovascular event by VH-IVUS combined with more than 70% plaque burden and less than 4mm² minimal lumen area (MLA) by IVUS. Fractional flow reserve (FFR) is an established index of the physiological significance of a coronary stenosis. Recent large scale trials demonstrated FFR guided PCI showed favorable clinical outcomes. VH-IVUS represents anatomical severity, but FFR represents functional severity of CAD. Few studies reported relevance between two tests. Aim of this study was to investigate whether the geometry and composition of lesions were different under FFR criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical angina pectoris who underwent VH-IVUS and FFR during coronary angiography.
- •agree with informed consent
排除标准
- •unable to get informed consent
- •low left ventricular ejection fraction less than 35%
- •chronic renal failure (Cr>2.0mg/dl)
- •acute myocardial infarction related coronary artery
- •allergy to adenosine injection
结局指标
主要结局
Differences VH-IVUS plaque composition between different FFR groups
时间窗: baseline
VH-IVUS tissue composition (necrotic core, dense calicium, fibrotic, fibrofatty %) and atheroma type will be compared according to different FFR groups at the time of measurement procedure.
次要结局
- Serial physiologic and plaque composition changes of deferred lesions at 1 year FFR and VH-IVUS follow-up.(one year)
- Serial physiologic and plaque composition changes of stented lesions at 1 year FFR and VH-IVUS follow-up.(one year)
研究者
Joon Hyung Doh
Associate Professor of Medicine
Inje University
