NCT04814550已完成不适用
Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2020年11月4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
- 318
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
研究概览
简要总结
This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from coronary angiography, with FFR as the reference standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age ≥18 years;
- •Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel;
- •Able to provide informed consent.
排除标准
- •Subjects judged unsuitable for diagnostic intervention or FFR;
- •Myocardial infarction within 6 days;
- •LVEF ≤50%;
- •eGFR <60ml/min（1.73m²）
- •Severe coagulation dysfunction or bleeding disorders;
- •Allergic to iodine contrast agent or adenosine, or ineligible for adenosine;
- •Participated in other clinical trials within 1 months;
- •Other situations that were not suitable for inclusion, as judged by investigators.
结局指标
主要结局
Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard
时间窗: 7 days
Hemodynamically significant coronary artery stenosis: FFR≤0.8
次要结局
- Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard(7 days)
- AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis(7 days)
研究者
研究点 (1)
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