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临床试验/NCT01444599
NCT01444599已完成不适用

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)

Inje University4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年3月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joon Hyung Doh

Associate Professor of Medicine

Inje University

研究点 (4)

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