Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain to Reduce Unnecessary Invasive Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 528
- 试验地点
- 2
- 主要终点
- Rate of unnecessary ICA
研究概览
简要总结
Rationale: Patients with stable chest pain enter a diagnostic pathway where Coronary Computed Tomography Angiography (CCTA) is often the first line non-invasive test to detect coronary stenosis. An anatomically significant (≥ 50% luminal narrowing) stenosis on CCTA does however not always cause cardiac ischemia (i.e. hemodynamically significant stenosis). CCTA is often followed by invasive coronary angiography (ICA) to assess the hemodynamic significance of the stenosis which is the key determinant to decide on treatment (revascularization by coronary stenting or surgery). CCTA has a very high negative predictive value but the positive predictive value is moderate. Hence, anatomically significant stenoses on CCTA often turn out not to be hemodynamically significant on ICA. Fractional Flow Reserve from coronary computed tomography (FFRct) analysis is a new non-invasive technique that uses the CCTA images as a basis for complex software based calculations and modelling to provide additional functional information based on the anatomical CCTA images. Thus, FFRct is a totally non-invasive method. Adding the FFRct analysis to the anatomical assessment of CCTA is expected to reduce the number of patients being referred to ICA where no signs of hemodynamically significant stenosis are found on ICA.
详细描述
In the Netherlands, annually 180.000 new patients present with stable chest pain - the most common symptom of coronary artery disease (CAD) [1]. Stable chest pain has a 1.5% 1-year mortality and 0.7% incidence of myocardial infarction [2]. The "Kennisagenda" of the Dutch Societies of Radiology and Cardiology include CAD diagnosis as a top 10 priority.
Patients with stable chest pain enter a diagnostic pathway to detect or exclude significant coronary stenosis which is defined as > 50% luminal narrowing.
The "Verbetersignalement pijn op de borst" published by the Zorginstituut, advocates that the diagnosis should be based on a single non-invasive first line test.
Based on the National Institute for Health and Excellence (NICE) and European Society of Cardiology (ESC) guidelines, the Coronary Computed Tomography Angiography (CCTA) is a good option as the first line test in low to intermediate risk patients.
CCTA is the most sensitive non-invasive technique available, but only provides anatomical information. CCTA has an excellent negative predictive value (99%), therefore CCTA can accurately rule out CAD. However the positive predictive value is moderate (64%). Hence, anatomically significant stenoses on CCTA often turn out not to be hemodynamically significant on ICA .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥ 18 years
- •Stable chest pain and the patient underwent CCTA which demonstrated ≥50% but less than 90% stenosis in any major epicardial vessel with a diameter ≥ 2 mm.
排除标准
- •Inability to provide informed consent
- •Unstable angina according to ESC guidelines
- •Unstable clinical status
- •Expected inability to complete follow-up and comply with follow-up aspects of the protocol
- •History of coronary revascularisation
- •Non-invasive or invasive diagnostic testing for CAD within the past 12 months (with the exception of exercise ECG)
- •Unsuitable for revascularisation if required (for example due to comorbidities or anatomical features)
- •Poor CT quality with expected inability to perform FFRct analysis
结局指标
主要结局
Rate of unnecessary ICA
时间窗: 90 days
Unnecessary ICA is defined as any ICA without hemodynamically significant CAD. The leading indicator for the evaluation of significant CAD is the functional measurement (FFR/iFR). If functional measurements are not available, then significant CAD is indicated by quantitative coronary angiography or ultimately by visual estimation (eyeballing).
次要结局
- Rate of major adverse cardiac events (MACE)(90 days; 1 year)
- Number of coronary revascularisations (planned/unplanned)(90 days; 1 year)
- EuroQoL 5-Dimension 5-Level (EQ5D5L) to measure quality of life(90 days; 1 year)
- Seattle Angina Questionnaire (SAQ) to quantify patients' symptoms of angina and the extent to which their angina affects their quality of life(90 days; 1 year)
- Cost-effectiveness(1 year)
- Number of additional non-invasive tests for coronary artery disease (CAD) assessment(90 days; 1 year)
- Rate of complications during and after ICA(90 days; 1 year)
- Rate of non-fatal stroke(90 days; 1 year)
- Rate of cardiovascular death(90 days; 1 year)
- Rate of unnecessary ICA(1 year)
- 36-Item Short Form Survey (SF-36) to measure quality of life(90 days; 1 year)
研究者
S.P. Sharma
Principal Investigator
Erasmus Medical Center