跳至主要内容
临床试验/NCT03045601
NCT03045601已完成不适用

Diagnostic Accuracy of Coronary Computed Tomographic Angiography Derived Fractional Flow Reserve Compared to Invasive Coronar Angiography With Fractional Flow Reserve

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2017年2月21日最近更新:
适应症

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

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

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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