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临床试验/NCT02240745
NCT02240745已完成不适用

New Three-dimensional Methods of Analysis for the Detection of Coronary Artery Disease by Dobutamine Stress Echocardiography

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年11月30日最近更新:
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
1
主要终点
Area Strain in the affected coronary artery stenosis myocardial segments (Reference: Coronary flow reserve CFR)

研究概览

简要总结

The investigators are going to recruit patients who have a scheduled elective coronary angiography and going to do a dobutamin stress echography (DSE) before the coronary examination. Next to a regular 2D-DSE, the investigators will perform an 3-dimensional DSE, incl ventriculography. In the interventional part (coronary angiography), they will measure each stenosis with fractional flow-reserve (FFR)and herewith graduate its stenosis severity.

详细描述

Background

Coronary heart disease is the leading cause of death worldwide. Non-invasive, radiation-free diagnostic needs further improvement. In this study, the investigators test the hypothesis that their method, which measures the myocardial deformation using 3D echocardiography is superior to previous ultrasound technologies with regard to diagnosis of stable coronary artery disease. The aim is establish an improved, non-invasive method to diagnose stable coronary artery disease.

Objective

The investigators want to investigate if a 3D-speckle-tracking is superior and more accurate in predicting hemodynamically significant coronary artery stenosis than predicted by 2D echocardiography? The reference variable for the hemodynamic significance of coronary artery stenosis is invasively measured by coronary flow reserve (CFR) in consideration of collateral flow (CFI).

Methods

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled elective coronary angiography
  • Age >/= 18 years
  • Written informed consent
  • Exclusion Criteria
  • Age < 18 years
  • Acute coronary syndrome
  • Unstable angina pectoris
  • Coronary 3-vessel disease
  • Left-main artery affected
  • Situation after myocardial infarction
  • Coronary anomaly
  • Situation after coronary bypass
  • Congenital heart disease
  • Pacemaker
  • Any contraindication concerning stress-echo

排除标准

  • 未提供

结局指标

主要结局

Area Strain in the affected coronary artery stenosis myocardial segments (Reference: Coronary flow reserve CFR)

时间窗: After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours

Area Strain (%) by Echocardiography

次要结局

  • Area at Risk: Surface Area of site with reduced strain relative to the total LV-surface(After dobutamin-stress-echocardiography, PTCA will be performed within aprox.1-3hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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