Feasibility of On-line Computed Fractional Flow Reserve: The Wire-free Invasive Functional Imaging (WIFI) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Feasibility of in-procedure QFR
研究概览
简要总结
Quantitative Flow Ratio (QFR) is a new method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections. The purpose of the WIFI study is to evaluate feasibility of QFR when performed during coronary angiography and compare diagnostic accuracy to standard FFR.
详细描述
Background:
Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG) and often in combination with measurement of fractional flow reserve (FFR) to assess the 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 maximum blood flow (hyperaemia) induced by adenosine infusion.
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 and the cost of the wire and the drug inducing hyperaemia limits more widespread adoption.
Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections.
The purpose of the WIFI study is to evaluate feasibility of QFR when performed during coronary angiography and compare diagnostic accuracy to standard FFR.
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
- •Stable angina pectoris and secondary evaluation of stenosis after acute myocardial infarction (AMI)
- •Age > 18 years
- •Signed informed consent
排除标准
- •Myocardial infarction within 72 hours
- •Severe asthma and chronic obstructive pulmonary disease
- •Severe heart failure (NYHA≥III)
- •S-creatinine>120µmol/L
- •Allergy to contrast media or adenosine
- •Stenosis in vein graft
- •Ostial left main stenosis
- •Severe tortuosity
- •Atrial fibrillation
结局指标
主要结局
Feasibility of in-procedure QFR
时间窗: 1 hour
Percentage of successful QFR in FFR-cases.
次要结局
- Contrast use(1 hour)
- Myocardial infarction(1 year)
- Proportion of patients with negative FFR (true negatives) of patients with negative QFR (negative predictive value)(1 hour)
- Diagnostic accuracy of QFR based on fixed hyperemic flow rate (in-procedure analysis)(1 hour)
- Proportion of patients with negative QFR of patients with negative FFR (true negatives) (specificity)(1 hour)
- Time to FFR(1 hour)
- Stent thrombosis(1 year)
- Diagnostic accuracy of QFR in comparison to 2D quantitative coronary angiography (QCA) (>50% diameter stenosis)(1 hour)
- Diagnostic accuracy of QFR based on TIMI flow with hyperemia (core laboratory analysis)(1 hour)
- Time to QFR(1 hour)
- Target lesion failure(1 year)
- Cardiac death(1 year)
- Non-cardiac death(1 year)
- Proportion of patients with positive FFR (true positives) of patients with positive QFR (positive predictive value)(1 hour)
- Any QFR procedure-related adverse events/complications (safety)(1 hour)
- Proportion of patients with positive QFR of FFR positive patients (true positives) (sensitivity)(1 hour)
- Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio(1 hour)
- Diagnostic accuracy of QFR based on Thrombolysis in Myocardial Infarction(TIMI) flow without hyperemia (in-procedure analysis)(1 hour)
- Fluoroscopy time(1 hour)
- Target lesion revascularization(1 year)
- Angina pectoris(1 year)
研究者
Niels Ramsing Holm
Research associate, M.D.
Aarhus University Hospital Skejby