Individual-Patient-Data Pooled-Analysis of Diagnostic Accuracy of Noninvasive Fractional Flow Reserve From Anatomic CT Angiography
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy of FFRCT
研究概览
简要总结
Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.
详细描述
Fractional Flow Reserve derived from computed tomography(FFRCT) is a novel method for determining the physiologic significance of coronary artery disease (CAD), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.
Available data from registered clinical trials has testified the diagnostic performance of FFRCT, but the diagnostic accuracy among them are not consistent.
Thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the diagnostic accuracy of FFRCT and find the possible cause for inconsistency
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Coronary computed tomographic angiography(CCTA) with over 50 percent stenosis in a major coronary artery over 2mm diameter
- •Undergoing clinically indicated invasive coronary angiography with FFR
排除标准
- •A history of CABG surgery
- •Prior percutaneous coronary intervention with suspected instent restenosis
- •Suspicion of or recent acute coronary syndrome
- •Complex congenital heart disease
- •Prior pacemaker or defibrillator
- •Prosthetic heart valve
- •Significant arrhythmia
- •heart rate >100 beats/min
- •systolic blood pressure≤90 mmHg
- •contraindication to beta blockers, nitroglycerin or adenosine
- •Serum creatinine level greater than 1.5 mg per dL
- •Allergy to iodinated contrast
- •Pregnant state
- •Body mass index greater than 35
- •Evidence of active clinical instability or lifethreatening disease
- •Canadian Cardiovascular Society class IV angina
- •nonevaluable CCTA as determined by the CCTA core laboratory
- •Inability to adhere to study procedures
结局指标
主要结局
Diagnostic Accuracy of FFRCT
时间窗: 1 day
Diagnostic accuracy\[Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)\]\* of FFRCT to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis at the subject level using binary outcomes when compared to FFR as the reference standard..\*Sensitivity measures the proportion of actual positives which are correctly identified. Specificity measures the proportion of negatives which are correctly identified;PPV, or precision rate is the proportion of positive test results that are true positives (such as correct diagnoses);NPV is defined as the proportion of subjects with a negative test result who are correctly diagnosed.
次要结局
- Diagnostic accuracy of FFRCT at the subject level(1 day)
- Diagnostic accuracy of FFRCT at the vessel level(1 day)
- FFR Numerical Correlation(1 day)
研究者
Ya-Wei Xu
MD,FACC
Shanghai 10th People's Hospital