Diagnostic Accuracy of Coronary Computed Tomographic Angiography Derived Fractional Flow Reserve Compared to Invasive Coronar Angiography With Fractional Flow Reserve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Worsening regional wall motion abnormality
研究概览
简要总结
Invasive coronary angiography is currently considered gold standard in the assessment of coronary artery disease although the method has limitations. Most importantly invasive angiography only depicts coronary anatomy without determining its physiological significance i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional flow reserve (FFR) is a catheterization technique for assessing the physiological significance of a coronary artery lesion during invasive coronary angiography. Coronary computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an alternative route to diagnosis for patients with suspected coronary artery disease. Computational fluid dynamics combined with anatomical models based on CCTA scans allows determination of coronary flow and pressure, and has emerged as a promising diagnostic modality called CT-FFR. In this Project New Mathematical algorithms are developed for computation of CT-FFR. The main objective of this study is to determine the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve and state-of-the-art dobutamin stress echocardiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven stenosis by CCTA that require further investigation with invasive coronary angiography i.e. patients with estimated stenosis ≥30- 50%.
- •Informed consent
排除标准
- •Patients with unstable coronary artery disease.
- •Previously treated with PCI or coronary surgery.
- •Severe renal impairment i.e. GFR <30ml / min
- •Contrast allergy
- •Contraindication to adenosine / nitroglycerin / beta-blocker
- •Patients referred on the basis of technically unsuccessful CTA, motion artifact or similar
结局指标
主要结局
Worsening regional wall motion abnormality
时间窗: 4 weeks
Determining the diagnostic accuracy of invasive FFR with comprehensive stress echocardiographic techniques
CT- FFR values by New Method as a dichotomous variable
时间窗: 4 weeks
Determining the diagnostic accuracy of CT-FFR values obtained by the new method compared with invasive coronary angiography with fractional flow reserve
次要结局
未报告次要终点
