Functional Diagnostic Accuracy of Quantitative Flow Ratio in On-line Assessment of Coronary Stenosis (The FAVOR II China Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 308
- 试验地点
- 5
- 主要终点
- Diagnostic accuracy of online QFR to determine presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.
研究概览
简要总结
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. The purpose of the FAVOR II China study is to evaluate the diagnostic accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies between online QFR and online QCA, with FFR as the reference standard.
详细描述
Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography. Lesions are often quantified by QCA, but fractional flow reserve is increasingly used to assess functional significance of identified stenosis. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperemia).
The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy in many centers but the need for interrogating the stenosis by a pressure wire, the cost of the wire, and the drug inducing hyperemia limits more widespread adoption.
QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two angiographic projections. The FAVOR Pilot study (Tu et al.) showed promising results for core laboratory QFR analysis in selected patients. However, the accuracy of QFR when assessed online in the catheterization laboratory is unknown. The purpose of the FAVOR II China study is to evaluate the diagnostic accuracy of on-line QFR with FFR as the reference standard. The secondary purpose is to compare the diagnostic accuracies between online QFR and online QCA, with FFR as the reference standard. It is a prospective and multi-center trial with a total of 308 patients conducted at 5 Chinese centers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Criteria:
- •Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI
- •Age > 18 years
- •Able to provide signed informed consent
- •Angiographic inclusion criteria:
- •At least one stenosis with diameter stenosis of 30%-90% by visual estimate
- •Reference vessel size > 2 mm in stenotic segment by visual estimate
排除标准
- •General Criteria:
- •Ineligible for diagnostic intervention or FFR examination
- •Myocardial infarction within 72 hours
- •Severe heart failure (NYHA≥III)
- •S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2
- •Allergy to contrast agent or adenosine
- •Factors that might substantially impact the angiographic image quality, e.g, frequent atrial premature beat or atrial fibrillation
- •Angiographic exclusion criteria:
- •The interrogated stenosis is caused by myocardial bridge
- •Ostial lesions less than 3 mm to the aorta
- •Side branches of the bifurcation lesions with Median Classification of 111 or 101
- •Poor angiographic image quality precluding contour detection
- •Severe overlap of stenotic segments
- •Severe tortuosity of target vessel
结局指标
主要结局
Diagnostic accuracy of online QFR to determine presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard.
时间窗: 1 hour
Presence of hemodynamically-significant coronary artery stenosis : FFR \<= 0.80.
次要结局
- The area under the receiver operating characteristic curve of online QFR in determining presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard(1 hour)
- In comparison to online 2D QCA, sensitivity and specificity of online QFR to determine presence or absence of hemodynamically-significant coronary artery stenosis at the vessel level using binary outcomes when compared to FFR as the reference standard(1 hour)
- The numerical difference between online QFR and core lab QFR.(1 hour)
- The numerical difference between online QFR and FFR.(1 hour)
- Feasibility of online computation of QFR(1 hour)
研究者
fuwaihospital
Professor
China National Center for Cardiovascular Diseases