NCT05694065进行中（未招募）不适用
Functional ComprEhensive AssessmenT by Intravascular UltrasoUnd Reconstruction in Patients With Suspected IschEmic Coronary Artery Disease (FEATURE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Diagnostic Accuracy of Onsite UFR
研究概览
简要总结
Investigating the diagnostic accuracy of online Ultrasonic Flow Ratio (UFR) assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived fractional flow reserve (FFR) as a reference standard.
详细描述
- Study overview This is a prospective, single-center, observational registry study of patients with suspected ischemic coronary artery disease. The purpose of this registry is to investigate the accuracy of online UFR assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived FFR as a reference standard.
- Study population and sample size calculation are based on the diagnostic performance of previous studies, where an accuracy of 92% was found for UFR. Investigators conservatively estimate the diagnostic accuracy of online UFR assessment as 90% for consecutively enrolled patient population, and with a test target value set as 78% at a two-side significance level of 0.05, statistical power as 90%. Considering incomplete FFR/UFR data of 10% at most, a total of 112 patients need to be enrolled.
- Participant enrollment was completed in November 2024; the study is currently in the follow-up phase with ongoing data collection and analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 be ≥ 18 years
- •Patients suspected with ischemic heart disease
- •≥ 1 diseased vessel with angiographic percent diameter stenosis between 40% and 80% in a vessel ≥ 2.5mm by visual estimation
- •Target vessels are limited to major epicardial coronary arteries (left anterior descending artery [LAD], left circumflex artery [LCX], right coronary artery [RCA])
排除标准
- •Patients with previous coronary artery bypass grafting (CABG)
- •Myocardial infarction within 72h of coronary angiography
- •Allergy to the contrast agent or adenosine
- •Left main coronary artery stenosis ≥ 50%
- •Target vessel with in-stent restenosis
- •Target vessel with severe tortuosity or angulation
- •100% occlusion of target vessel
- •Target vessel spasm or injury
- •Target vessel with severe myocardial bridge
- •Target vessel with severe thrombosis
- •Intravascular ultrasound (IVUS) pullback fails to cover the complete target lesion
- •Presence of false lumen at target vessel based on IVUS
- •A serum creatinine level >150 umol/l, or a glomerular filtration rate < 45 ml/kg/1.73 m^2
- •Heart failure
- •Ineligible for diagnostic intervention (IVUS or FFR examination)
结局指标
主要结局
Diagnostic Accuracy of Onsite UFR
时间窗: baseline
UFR was computed as the pressure ratio across a coronary stenosis, using FFR ≤0.80 as the reference standard for hemodynamically significant stenosis. The diagnostic performance of onsite UFR was assessed by the area under the receiver operating characteristic (ROC) curve analysis, with diagnostic accuracy defined as the percentage of all correctly classified cases (true positives and true negatives) in the total population.
次要结局
- Sensitivity of Onsite UFR(baseline)
- Specificity of Onsite UFR(baseline)
- Sensitivity of Minimal Lumen Area (MLA)(baseline)
- Specificity of MLA(baseline)
研究者
研究点 (2)
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