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临床试验/NCT02388399
NCT02388399Unknown不适用

Relevance of Invasively Measured Axial Plaque Stress and Wall Shear Stress Using Invasive Coronary Imaging and Hemodynamic Data

Seoul National University Hospital4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
4
主要终点
Cap thickness (measured from optical coherent tomography)

研究概览

简要总结

In this study, the investigators sought to evaluate the feasibility of estimating external hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from pressure wire pullback tracing.

In addition, the investigators will also evaluate detailed plaque geometry and vulnerability using optical coherence tomography along with the hemodynamic stress.

详细描述

It has been well known that mechanism of acute coronary syndrome is plaque rupture and occlusion of coronary artery by this plaque rupture. Although current risk assessment for plaque rupture have mainly focused on evaluation of plaque vulnerability. However, according to the general mechanism of material failure, plaque rupture occurs whenever the external hemodynamic stress exceeds the durability of the plaque.

Recently, we evaluated the axial plaque stress, which is axial component of total traction acting on the plaque, and showed that the axial plaque stress possess significantly higher magnitude than previously known wall shear stress.

However, the axial plaque stress in our previous research was measured with computational flow dynamics analysis using coronary artery model from coronary CT angiography.

In this study, we sought to evaluate the feasibility of estimating external hemodynamic stress acting plaque with the use of invasively measured hemodynamic data from pressure wire pullback tracing.

In addition, we will also evaluate detailed plaque geometry and vulnerability using optical coherence tomography along with the hemodynamic stress.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with angina pectoris who are scheduled to do invasive coronary angiography.
  • Patients who have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries.
  • Pressure wire pullback tracing and Optical Coherence Tomography ware successfully performed

排除标准

  • Stenosis at distal coronary or small vessel.
  • Patients who don't have moderate (40-70%) stenosis at proximal or mid-portion of major coronary arteries. Confirmed by invasive coronary angiography.
  • Inadequate quality of Optical Coherence Tomography
  • No data of Fractional Flow Reserve or Pressure wire pullback tracing or inadequate data of Fractional Flow Reserve or Pressure wire pullback tracing

结局指标

主要结局

Cap thickness (measured from optical coherent tomography)

时间窗: up to 1 week

Cap thickness measured from optical coherent tomography

Axial plaque stress (Axial component of total traction acting on the plaque)

时间窗: up to 1 week

次要结局

  • Proportion of thin cap fibrous atheroma(up to 1 week)
  • Target vessel restenosis(1 year)
  • Wall shear stress (Friction vector on the surface of the plaque)(up to 1 week)
  • Non-fatal target vessel myocardial infarction(1 year)
  • Cardiac death and all-cause mortality(1 year)

研究者

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

Bon-Kwon Koo

Professor of Internal Medicine and Cardiology Deparment

Seoul National University Hospital

研究点 (4)

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