NCT04426396已完成不适用
Coronary CT 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 339 人开始时间: 2020年4月15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
- 339
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of CT-FFR compared to FFR
研究概览
简要总结
This is a blind evaluation, self-control, multicenter clinical trial designed to determine the diagnostic performance of CT-FFR from coronary computed tomographic angiography (CCTA), as compared to CCTA alone, for non-invasive diagnosis of the presence of a hemodynamically significant coronary stenosis, using invasive fractional flow reserve (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 old;
- •Subjects with clinical need and consent for coronary angiography;
- •Can provide the results of coronary CT angiography within 60 days prior to ICA or agree to undergo coronary CT angiography;
- •The subjects knew about the experiment and signed the informed consent voluntarily.
排除标准
- •Patients who have had percutaneous coronary intervention (PCI);
- •Patients who had CABG;
- •Acute coronary syndrome, such as acute ST segment elevation;
- •Severe tachycardia or arrhythmia;
- •Patients with severe hepatorenal insufficiency;
- •Patients with congenital heart disease, implanted pacemaker or defibrillator, artificial heart valve;
- •Failure to perform invasive FFR examination or obtain FFR value due to various reasons;
- •Allergic to β - blockers, nitrates and adenosine, sick sinus syndrome, long QT syndrome, severe hypotension, severe asthma, severe COPD or COPD;
- •Persistent or significant clinical instability, including acute chest pain (sudden onset), cardiogenic shock, blood pressure instability (systolic blood pressure < 90mmHg) and severe congestive heart failure (according to the heart classification of the New York Heart Association, grade III or IV of cardiac function) or acute pulmonary edema;
- •The CTA images of coronary artery showed that the stenosis rate was less than 30% or greater than 90%, or the diameter of diseased segment was less than 2.0mm;
- •CT-FFR can not be calculated because of the quality of CTA image;
- •Known pregnant and lactating women;
- •Having participated in other clinical trials within 3 months;
- •Other situations that the researchers judged were not suitable for inclusion.
结局指标
主要结局
Sensitivity and specificity of CT-FFR compared to FFR
时间窗: 1 day
次要结局
- Diagnostic accuracy and AUC of CT-FFR compared to FFR(1 day)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
CT-FFR-guided Strategy for In-stent RestenosisIn-stent RestenosisCoronary Artery DiseaseNCT05611190Yan'an Affiliated Hospital of Kunming Medical University294
Unknown
不适用
Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)Coronary DiseaseCoronary Artery DiseaseHeart DiseasesCardiovascular DiseasesArterial Occlusive DiseasesVascular DiseasesArteriosclerosisMyocardial IschemiaNCT04142021National University of Ireland, Galway, Ireland114
已完成
不适用
Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary AngiographyCoronary Artery DiseaseNCT04814550Second Affiliated Hospital, School of Medicine, Zhejiang University318
已完成
不适用
Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel DiseaseMulti Vessel Coronary Artery DiseaseNCT03455244CathWorks Ltd.50
尚未招募
不适用
IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)ICAS - Intracranial AtherosclerosisNCT05974033Changhai Hospital536