Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment
赞助:
Chinese Academy of Medical Sciences, Fuwai Hospital
合作者:
信息的提供 (责任方):
Bin Lu，Chinese Academy of Medical Sciences, Fuwai Hospital
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 30, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | November 1, 2018 | ||
| 预计主要完成日期 | August 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
sensitivity and specificity of CT-FFR compared with CCTA[ Time Frame: 7days ] In comparison to CCTA, sensitivity and specificity of CT-FFR determine whether a subject has hemodynamically-significant coronary artery lesions using binary outcomes when compared to invasive FFR as the reference standard. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment | ||
| 正式标题 ICMJE | Computed Tomography Derived Fractional Flow Reserve for Coronary Hemodynamic Ischemia Noninvasive Assessment (CT-FFR-CHINA) | ||
| 简要概况 | Computed Tomography Derived Fractional Flow Reserve (CT-FFR) is a noninvasive method for evaluating the hemodynamic significance of coronary artery lesions by using coronary CT Angiography (CCTA) as opposed to invasive FFR examination under invasive coronary angiography. The purpose of the CT-FFR-CHINA study is to verify that the diagnostic performance of hemodynamically significant lesions by CT-FFR is superior than routine anatomic evaluation of diameter stenosis using CCTA alone using invasive FFR as the reference standard, exclusively in Chinese population. |
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| 详细说明 | Numerous studies have demonstrated high diagnostic accuracy of CCTA to detect and exclude coronary artery disease (CAD). One main limitation of CCTA, however, is a tendency to overestimate the severity of coronary artery stenosis against invasive coronary angiography (ICA). On the other hand, FFR, invasively measured under ICA, is recognized as the current gold standard in determination of coronary artery lesions due to improved long-term clinical outcomes when revascularization is guided by FFR instead of ICA. Moreover, prior studies indicated unreliable relationships between detection of obstructive anatomic coronary artery stenoses defined by CCTA and hemodynamically significant lesions by invasive fractional flow reserve (FFR). Recent advances in artificial intelligence and computational modeling techniques now permit construction of a 3-dimensional model of coronary arteries visible from CCTA images and computation of FFR anywhere in the entire 3D model noninvasively. Several prior prospective, multicenter studies have reported promising results for the diagnostic performance of CT-FFR using invasive FFR as the reference standard. However, the diagnostic performance of CT-FFR in Chinese population is not clear. Therefore, we hereby designed the CT-FFR-CHINA study to determine the hemodynamically significant lesions, exclusively in Chinese subjects. It is a prospective and multi-center trial with a total of 326 subjects enrolled at 4 Chinese centers. | ||
| 研究类型 ICMJE | Observational [Patient Registry] | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational [Patient Registry] 盲法描述: 主要目的: |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
326 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 30, 2019 | ||
| 预计主要完成日期 | August 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - General Criteria: - Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI - Age > 18 years - Able to provide signed informed consent CCTA 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 Exclusion Criteria: - 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 CCTA 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 - Poor angiographic image quality precluding contour detection - Severe overlap of stenotic segments - Severe tortuosity of target vessel | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Bin Lu，Chinese Academy of Medical Sciences, Fuwai Hospital | ||
| 研究赞助商 ICMJE | Chinese Academy of Medical Sciences, Fuwai Hospital | ||
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| PRS 账户 | Chinese Academy of Medical Sciences, Fuwai Hospital | ||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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