Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of CT-FFR
研究概览
简要总结
The current study evaluated the diagnostic performance for myocardial ischemia of on-site automatic CCTA-derived FFR (CT-FFR) using a commercially available workstation as compared with invasive FFR as a reference. The diagnostic performance of CT-FFR was compared to that of CCTA diameter stenosis.
详细描述
This is a retrospective, multicenter, comparative, investigator-initiated study to evaluate the diagnostic performance of CT-FFR from routinely acquired CCTA data using the software HeartMedi+ 1.0 (AI Medic, Korea) to detect hemodynamically significant CAD. Patients who underwent CCTA within 90 days before invasive coronary angiography and FFR measurement will be screened in each participating center. After that, invasive coronary angiography, FFR data, and CCTA data will be anonymized and transferred to the independent core laboratories and analyzed in a blind fashion.
The presence of ischemia was defined as FFR ≤0.80. Anatomical obstructive stenosis was defined as diameter stenosis on CCTA ≥50%, and the diagnostic performance of CT-FFR and CCTA stenosis for ischemia was compared.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 20 years or older
- •individuals who had undergone ≥ 64 multidetector row CCTA within 90 days before invasive coronary angiography and FFR measurement
- •individuals who had not experienced any clinical events or significant clinical changes between the time of CCTA and invasive coronary angiography
排除标准
- •previous coronary intervention or coronary bypass surgery in the target vessel
- •invasive coronary angiography under unstable conditions
- •previous myocardial infarction at target vessel territory
- •congenital heart disease
- •moderate or severe valvular heart disease
- •previous valvular heart surgery
- •left ventricular ejection fraction ≤40% or left ventricular hypertrophy
- •previous cardiac device implantation
- •body mass index >35 kg/m2
- •poor FFR tracing quality
- •no information on the position of the FFR pressure wire
- •heart rate ≥100 beats/min during CCTA
- •CCTA calcium score ≥1000
- •no nitroglycerin prior to CCTA
- •CCTA slice thickness >1.0 mm
- •significant artifacts in CCTA
结局指标
主要结局
Diagnostic accuracy of CT-FFR
时间窗: At the time of test
Diagnostic accuracy of CT-FFR to detect hemodynamically significant CAD evaluated with an invasive FFR
次要结局
- Agreement between CT-FFR and FFR(At the time of test)
- Comparison of diagnostic performance of CT-FFR to that of CCTA stenosis(At the time of test)
- Spearman's correlation coefficient of CT-FFR with FFR(At the time of test)
- Comparison of discriminant ability of CT-FFR to that of CCTA stenosis(At the time of test)
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital