Multicenter Registry for Diagnostic Accuracy of Angiography-Derived Quantitative Flow Ratio to Evaluate the Hemodynamic Significance of Coronary Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 524
- 试验地点
- 5
- 主要终点
- Diagnostic accuracy of QFR
研究概览
简要总结
- to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio (QFR) for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease (CAD) including presentation of acute myocardial infarction (AMI) with non-culprit lesion.
- to compare the changes of contrast QFR and fractional flow reserve (FFR) according to severity of percent diameter stenosis (%DS)
- to evaluate prognostic implication of contrast QFR in comparison with FFR
详细描述
Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous coronary intervention (PCI), adoption rate of FFR is still low in real world practice, most likely due to use of additional resource and to concern about side effects of hyperemic agent. Therefore, several tools to derive FFR non-invasively has been developed based on computational fluid dynamics to overcome the limitations. One of the novel methods, the contrast quantitative flow ratio (QFR) is a computation of FFR based on 3-dimensional quantitative coronary angiography (QCA) combined with Thrombolysis in Myocardial Infarction (TIMI) frame counts adjustment without hyperemic agent infusion.
Although diagnostic performance of contrast QFR for evaluation of functional significance, using FFR as reference standard, is well validated in patients with stable ischemic heart disease (SIHD), there have been lack of evidence regarding the reliability of QFR for non-culprit stenosis in patients with AMI.
Therefore, the investigators sought to investigate the feasibility and diagnostic performance of contrast QFR for identifying the functional significance of coronary stenosis in all-comer patients with CAD. In addition, prognostic implication of contrast QFR will be also compared with that of FFR.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be ≥18 years
- •Patients suspected with ischemic heart disease
- •Patients with intermediate degree of coronary artery stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery with FFR measurement
- •Patients who were able to analyze QFR
- •Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides
排除标准
- •Left main (LM) or right coronary artery (RCA) ostial lesion
- •Severe overlap of stenotic segments
- •Severe tortuosity of target vessel
- •Poor angiographic image quality precluding contour detection
- •No optimal images with angles ≥ 25o
结局指标
主要结局
Diagnostic accuracy of QFR
时间窗: through study completion, an average of 6 months
Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8
Vessel-related composite outcome
时间窗: through study completion, an average of 2 year
a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization
次要结局
- Sensitivity of QFR(through study completion, an average of 6 months)
- Specificity of QFR(through study completion, an average of 6 months)
- Correlation between QFR and FFR(through study completion, an average of 6 months)
研究者
Joo Myung Lee
Assistant Professor
Samsung Medical Center