Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 主要终点
- Sensitivity
研究概览
简要总结
Coronary CT Angiography (CCTA) may be an ideal modality to fill gaps in understanding the extent and rate of progression coronary artery disease. The investigators have developed an image analysis software ElucidVivo that estimates relevant indices, including fractional flow reserve (FFR) . In this study, the investigators aim to assess the value of ElucidVivo-based plaque morphology characterization for predicting non-invasive FFR in patients with suspected coronary artery disease (CAD) who had undergone clinically indicated coronary CTA and invasive coronary angiography (ICA) for physical FFR measurement.
详细描述
Invasive FFR is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decisions regarding coronary revascularization. FFR derived from coronary CTA (FFRct) using computational fluid dynamics (CFD)-based software has been shown to be a reasonably accurate estimate of invasive FFR and is included in contemporary guidelines as a decision-tool for management of patients with intermediate stenosis on coronary CTA. However, other methods have limitations. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen stenosis, significantly impacts the vasodilatory capacity of the vessel walls which may provide a more interpretable analysis and broader clinical acceptance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease.
- •CCTA was no more than 60 days earlier (and not later)
排除标准
- •Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG)
- •Subject with insufficient CCTA image quality (defined strictly as documented in the ElucidVivo Reading Manual)
结局指标
主要结局
Sensitivity
时间窗: 1 day
the ability of a test to correctly identify patients with low FFR
Specificity
时间窗: 1 day
the ability of a test to correctly identify people without low FFR
次要结局
- Average Error(1 day)