Diagnostic Accuracy of Quantitative Flow Ratio for Hemodynamic Assessment of Coronary Artery Stenosis: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of QFR
研究概览
简要总结
The aim of this study was to investigate the accuracy of quantitative flow ratio (QFR) for predicting fractional flow reserve (FFR) ≤0.80 in an independent core laboratory.
详细描述
FFR is an invasive physiological index used to define coronary stenosis that causes ischemia. Several studies have suggested that FFR-based percutaneous coronary intervention (PCI) can reduce adverse clinical outcomes compared to angiography-guided PCI. Although FFR is highly recommended in current guidelines, it is underused in real-world practice. QFR is a method for evaluating fractional flow reserve FFR without the use of an invasive coronary pressure wire or pharmacological hyperemic agent.
The aims of this study were:
- To investigate diagnostic accuracy of angiography-based QFR for hemodynamic assessment of coronary artery stenosis compared to pressure wire-based FFR.
- To compare the diagnostic performance of QFR versus % diameter stenosis (DS) in identifying physiologically significant coronary artery disease (CAD) using FFR as the reference standard.
- To identify factors affecting QFR accuracy.
- To compare the coronary CT data with QFR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suspected with CAD undergoing diagnostic coronary angiography with an indication for to perform invasive FFR
排除标准
- •Suboptimal angiographic image quality for QFR analysis
- •Primary myocardial or valvular disease
- •Left ventricular ejection fraction ≤40%
- •Patients with cardiogenic shock
结局指标
主要结局
Diagnostic accuracy of QFR
时间窗: through study completion, an average of 1 year
Diagnostic accuracy of QFR (≤0.80 or \>0.80) to determine hemodynamically significant coronary stenosis using invasive FFR (≤0.80 or \>0.80) as a reference standard
次要结局
- Specificity of QFR(through study completion, an average of 1 year)
- Correlation(through study completion, an average of 1 year)
- Sensitivity of QFR(through study completion, an average of 1 year)
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital